Devices and techniques for vascular compression

ABSTRACT

The present disclosure provides for specific shapes and combinations of the compression members amenable to the safest, yet most effective compression of the carotid and vertebral arteries aimed at prevention of embolic stroke. An associated method of achieving an optimal compression of said arteries for the purpose of stroke prevention is provided.

RELATED APPLICATIONS

The present application is a continuation application and claims thebenefit of U.S. application Ser. No. 16/364,345 filed on Mar. 26, 2019and entitled, “Devices and Techniques for Vascular Compression,” thecontents of which are incorporated by reference herein in their entiretyfor all purposes. U.S. application Ser. No. 16/364,345 is a divisionalapplication and claims the benefit of U.S. application Ser. No.15/008,276 filed on Jan. 27, 2016 which issued on Apr. 16, 2019 as U.S.Pat. No. 10,258,348 and entitled, “Devices and Techniques for VascularCompression,” the contents of which are incorporated by reference hereinin their entirety for all purposes. U.S. application Ser. No. 15/008,276claims the benefit of U.S. Provisional Application No. 62/108,059, filedon Jan. 27, 2015, entitled “Shape and Configuration of the Carotid andVertebral Compression Members for Safe and Effective VascularCompression and Prevention of Stroke and Method of Use,” which isincorporated by reference herein in its entirety. U.S. application Ser.No. 15/008,276 also claims the benefit of U.S. Provisional ApplicationNo. 62/142,431, filed on Apr. 2, 2015, entitled “Shape and Configurationof the Carotid and Vertebral Compression Members for Safe and EffectiveVascular Compression and Prevention of Embolic Stroke and Method ofUse,” which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

The subject technology relates to prevention of embolic and ischemicinjury (such as ischemia and stroke) as a consequence of emboligenicevents and interventions.

BACKGROUND

Arterial embolism, leading to embolic ischemia or stroke, is one of themost dreadful complications of cardiac, aortic and vascular procedures,diagnosed in 1-22% of patients undergoing cardiovascular surgery. Evenmore frequently, in up to 86% of cases, patients undergoing heart,valve, coronary artery bypass, aortic surgery, cardiac catheterization,or even simple endovascular interventions experience subclinical embolicevents as recorded by transcranial Doppler or magnetic resonance imaging(MRI). These embolic events can lead to cognitive impairment,disability, extremity ischemia, multiple organ failure, dementia, anddeath having a significant impact on patients' recovery. With more than1.2 million cardiovascular procedures performed in the United Statesalone, this issue has a significant socio-economic impact.

The main sources of emboli in this setting reside in the heart, heartvalves, thoracic aorta, and great vessels when these structures areintervened thereon (i.e. when an emboligenic procedure is performed).Even simple cardiac catheterization with an endovascular catheter caninduce microtrauma of the atherosclerotic thoracic aorta leading toformation of embolic particles with subsequent embolic brain, liver,kidney and extremity injury ranging from latent ischemic foci to amassive or even fatal event. Multiple devices are known that attempt toprevent embolization of the carotid arteries during endovascular andcardiac interventions by using different types of filters, deflectiondevices, endoluminal balloons, shields, or other embolic traps ordeflectors. These anti-embolic devices, however, have not received wideacceptance in surgery of the heart, heart valves and thoracic aorta dueto their complexity and invasive character with the risk of additionaltrauma to the inner vessel wall resulting in a high risk to benefitratio. Known devices require insertion of additional hardware into thearterial system or aorta, a procedure that is known by itself to beassociated with all classical risks of endovascular intervention,including aortic dissection, bleeding, thrombosis, and arterialembolization. One known intra-aortic filter device that is inserted intothe ascending portion of the thoracic aorta via an aortic cannula tocapture potential embolic material released from the heart and aorticwall during heart surgery was found to be quite difficult to implementand was reported to be associated with major trauma to aortic wall andacute aortic dissection.

Aside from introducing hardware into the patient and causing theaforementioned problems, intravascular filters are not able to captureembolus smaller than the pore size of the available devices (currently60-140 μm) resulting in cerebral microembolization. Furthermore, theplacement of the filter by itself may produce cerebral emboli. Forexample, the mere passing of a guide wire into a carotid arterygenerates approximately 40,000 microemboli, with a significantpercentage of small, less than 60 μm, particles that are not retained bystandard filters. Therefore, in spite of multiple innovations in thefield of anti-embolic devices, the problem of arterial emboli and strokeduring cardiovascular surgery is far from being resolved. As such, thereremains room for variation and improvement within the art.

SUMMARY

Embodiments of the present disclosure relate to devices and techniquesfor vascular compression. More particularly, the present disclosurerelates to a device having compression members of a specificcross-sectional shape or combination of cross-sectional shapes forvascular compression, such as compression of arteries.

In accordance with the present disclosure, there is provided a devicefor diverting emboli from a cerebral circulation of a patient. Thedevice comprises a first compression member configured to be applied toa first artery of the patient when the device is placed around a neck ofthe patient, the first compression member having an unactuated state andan actuated state, wherein the first compression member has ananatomically congruent cross-sectional shape such that, when in theactuated state, the first compression member applies a greater, amountof force on the artery than on a trachea or a sternocleidomastoid muscleof the patient. The device also comprises a second compression memberconfigured to be applied to a second artery of the patient when thedevice is placed around the neck of the patient, the second compressionmember having an unactuated and an actuated state, wherein the secondcompression member has an anatomically congruent cross-sectional shapesuch that, when in the actuated state, the second compression memberapplies a greater amount of force on the second artery than on thetrachea or a sternocleidomastoid muscle of the patient.

In accordance with other, aspects of the disclosure, the device furthercomprises a third compression member configured to be applied to a thirdartery of the patient when the device is placed around the neck of thepatient, the third compression member having an unactuated state and anactuated state, wherein the third compression member has an anatomicallycongruent cross-sectional shape configured such that, when in theactuated state, the third compression member applies a greater amount offorce on the third artery than on an anterior scalenus muscle, a longuscolli muscle, or a sternocleidomastoid muscle of the patient. The devicealso comprises a fourth compression member configured to be applied to afourth artery of the patient when the device is placed around the neckof the patient, the fourth compression member having an unactuated stateand an actuated state, wherein the fourth compression member has ananatomically congruent cross-sectional shape configured such that, whenin the actuated state, the fourth compression member applies a greateramount of force on the fourth artery than on an anterior scalenusmuscle, a longus colli muscle, or a sternocleidomastoid muscle of thepatient.

In accordance with additional aspects of the disclosure, across-sectional shape of the first compression member is one of an ovalshape, a conic, shape, a pear shape, a bilobar shape, a trilobar shape,a finger shape, or a multiple finger shape.

In accordance, with further aspects of the disclosure, the secondcompression member comprises two compression members, a first of the twocompression members having an arcuate or crescent cross-sectional shape,and a second of the two compression members having a conic, oval or pearcross-sectional shape.

In accordance with still further aspects of the disclosure, at least oneof the first compression member or the second compression membercomprises foam.

In accordance with other aspects of the disclosure, at least one of thefirst compression member or the second compression member is inflatable.

In accordance with still other aspects of the disclosure, the device hasa hinge positioned between the first compression member and the secondcompression member, wherein the hinge is configured to be actuated toadjust one of a distance between the first compression member and thefirst artery and a distance between the second compression member andthe second artery. The hinge may be capable of providing a differentdegree of angulation between a left portion and a right portion of thecompression device at a level of a cervical portion of a trachea of thepatient.

In accordance with additional aspects of the disclosure, the firstcompression member is disposed in an insertion pocket of the device, theinsertion pocket being adapted for removal of the first compressionmember and insertion of a third compression member that is different incross-sectional shape than the first compression member.

In accordance with other aspects of the disclosure, the first artery isa carotid artery.

In accordance with still other aspects of the disclosure, the thirdartery is a vertebral artery.

In accordance with further aspects of the disclosure, the firstcompression member includes a Doppler probe configured to detect embolicparticles in the first artery. In accordance with some embodiments, athird compression member may include a Doppler probe configured todetect embolic particles in a third artery.

In accordance with other aspects of the disclosure, the firstcompression member includes one of a Doppler probe or a pulse oximeterconfigured to detect a correct amount of compression on the firstartery. In accordance with some embodiments, the first compressionmember may detect moving particles in the first artery, which mayreflect potential vascular emboli.

In accordance with still other aspects of the disclosure, the firstcompression member has a cross-sectional multiple finger shape and isconfigured to compress along a length of the first artery.

In accordance with further aspects of the disclosure, the firstcompression member, when actuated, is configured to exert pressure ontothe trachea and the sternocleidomastoid muscle so as to stabilize thefirst compression member on the first artery.

In accordance with other aspects of the disclosure, the device isconfigured to be positioned adjacent to the trachea, and the portion ofthe device adjacent to the trachea is narrower in a longitudinaldirection parallel to the longitudinal axis of the neck than a portionof the device including the first compression member.

In accordance with additional aspects of the disclosure, the firstcompression member assumes the cross-sectional shape when in itsactuated, state.

In accordance with further aspects of the disclosure, the hinge can be,actuated to adjust an angle formed by the hinge between a side of thedevice comprising the first compression member and a side of the devicecomprising the second compression member, wherein the angle is between35 degrees and 140 degrees when the first compression member and thesecond compression member are in their actuated states.

In accordance with still further aspects of the disclosure, an anglebetween a longitudinal axis of the first artery and a longitudinal axisof the first compression member is between 0 and 65 degrees when thefirst compression member is in its actuated state.

In accordance with other aspects of the disclosure, the thirdcompression member includes a Doppler probe configured to detect embolicparticles in the third artery.

In accordance with further aspects of the disclosure, the thirdcompression member includes one of a Doppler probe or a pulse oximeterconfigured to detect a correct amount of compression on the thirdartery.

Furthermore, in accordance with the present disclosure, there isprovided a kit for use in diverting emboli from a cerebral circulationof a patient. The kit comprises a compression device for placementaround a neck of the patient, the compression device having insertionslots. The kit also comprises compression members, wherein at least afirst of the compression members has a different cross-sectional shapethan a second of the compression members, and wherein each of the firstand second compression members are configured for insertion into one ofthe insertion slots.

In accordance with aspects of the disclosure, the kit comprises a sizingtemplate with a size and curvature, wherein the sizing template isconfigured to provide measurement between arteries of the neck of thepatient.

In accordance with other aspects of the disclosure, the kit comprises aplurality of different sizing templates, each of the sizing templateshaving a unique size or curvature.

In accordance with further aspects of the disclosure, the firstcompression member has a cross-sectional shape that is one of an ovalshape, a conic shape, a pear shape, a bilobar shape, a trilobar shape, afinger shape, or a multiple finger shape.

In accordance with additional aspects of the disclosure, the firstcompression member comprises two compression members, a first of the twocompression members having an arcuate or crescent cross-sectional shape,and a second of the two compression members having a conic, oval, orpear cross-sectional shape.

In accordance with other aspects of the disclosure, the kit comprises aplurality of compression devices, wherein each of the compressiondevices has a different size.

In accordance with further aspects of the disclosure, the compressiondevice has two insertion slots, each of which is configured forpositioning along an artery of the patient.

In accordance with additional aspects of the disclosure, the compressiondevice has four insertion slots, each of which is configured forpositioning along an artery of the patient.

In accordance with other aspects of the disclosure, at least one of thefirst or second compression members comprises foam.

In accordance with further aspects of the disclosure, at least one ofthe first or second compression members is inflatable.

Additionally, in accordance with the present disclosure, there isprovided a method of diverting emboli from cerebral circulation of apatient. The method comprises determining an anatomical characteristicof a neck of the patient, and selecting a compression member having aparticular cross-sectional shape from a plurality of compression membersbased on the characteristic. The method also comprises coupling thecompression member to a compression device. The method further comprisespositioning the compression member at an artery of the patient bypositioning the compression device around the neck of the patient. Themethod still further comprises actuating the first compression member tocompress the artery.

In accordance with aspects of the disclosure, the method furthercomprises selecting the compression device from a plurality ofcompression devices based on a size of the compression device and thedetermined anatomical characteristic of the neck of the patient.

In accordance with other aspects of the disclosure, the method furthercomprises measuring the distance between the artery and another arteryof the patient using a sizing template to determine the characteristicof the neck of the patient.

In accordance with further aspects of the disclosure, the method stillfurther comprises adjusting an angle of a hinge of the compressiondevice such that an angle of the hinge is between 35 degrees and 140degrees when the first compression member is actuated.

Still further, in accordance with the present disclosure, there isprovided a method of diverting emboli from a cerebral circulation of apatient. The method comprises placing a compression device around a neckof the patient, such that a compression member attached to thecompression device is positioned for application of pressure to anartery. The method also comprises actuating the compression member toapply force to the artery, wherein an amount of the force applied by thecompression member to the artery is greater than an amount of forceapplied by the compression member to a trachea or a sternocleidomastoidmuscle of the patient.

Before explaining example embodiments consistent with the presentdisclosure in detail, it is to be understood that the disclosure is notlimited in its application to the details of constructions and to thearrangements set forth in the following description or illustrated inthe drawings. The disclosure is capable of embodiments in addition tothose described and is capable of being practiced and carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein, as well as in the abstract, are for thepurpose of description and should not be regarded as limiting.

It is to be understood that both the foregoing general description andthe following detailed description are explanatory only and are notrestrictive of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying, drawings, which are incorporated in and constitutepart of this specification, and together with the description,illustrate and serve to explain the principles of various exampleembodiments.

FIG. 1 is an example of a view of a blood vessel, with the blood in thevessel carrying emboli. The blood vessel branches into vessels carryingthe blood to different areas and organs.

FIG. 2 is an example of a view of a blood vessel, with the blood in thevessel carrying emboli, where an external compression of a branchcarrying blood to an organ (such as a brain) will divert the emboli toanother vessel.

FIG. 3 is an example schematic representation of a method of protectionfrom vascular emboli with an option of an automated external compressionof an artery carrying blood to an organ.

FIG. 4 represents an example mechanism of detecting embolic particlesupstream from an organ to be protected with an automated feedbacksignaling system that is able to trigger a process of arterial or venouscompression to limit entry of emboligenic particles into the organ.

FIGS. 5 and 6 show an example of compression of an artery, triggered bydetection of the embolic particles in an afferent vessel, cardiacsystole, or other parameters with subsequent diversion of emboli into aless important blood vessel.

FIG. 7 shows an example of a release of arterial compression onceembolic particles are diverted away from an organ to be protected on thebasis of a negative feedback mechanism, triggered by disappearance ofembolic particles in an afferent vascular pathway, excessive time orlength of compression, or other parameters.

FIG. 8 is an example of a front view of a patient with embolic particlesin the heart and ascending thoracic aorta with a potential forpropagation into both carotid arteries and other vessels with the sourceof emboli being diseased aorta, aortic valve and/or the heart.

FIG. 9 is an example of a front view of a patient with release ofembolic particles arising in the heart, aortic valve and/or aorta, intosystemic circulation, including both carotid and vertebral arteries, anddescending thoracic aorta.

FIG. 10 shows an example of accentuation of a process of arterialembolization during cardiac contraction (systole).

FIG. 11 is an example of a front view of a patient with externalcompression of both carotid and vertebral arteries that leads totemporary diminution or interruption of a cerebral arterial inflow,protecting a brain from potential emboli.

FIG. 12 is an example of a front view of a patient with externalcompression of both carotid and vertebral arteries during cardiaccontraction.

FIG. 13 is an example of a front view of a patient with externalcompression of carotid and/or vertebral arteries by virtue of anexternal compression device and mechanism, actuated by certainphysiological parameters.

FIG. 14 is an example of a schematic view of a device for carotid and/orvertebral compression, depicted on FIG. 13 .

FIG. 15 is an example of a cross-sectional view of a neck of a patientand a device attached thereto in an unactuated state.

FIG. 16 is an example of a cross-sectional view of a neck of a patientand a device attached thereto in an actuated state.

FIG. 17 is an example of a front view of a patient with a compressiondevice in accordance with another exemplary embodiment, leading toselective compression of vertebral arteries.

FIG. 18 is an example of a front view of a patient with a compressiondevice for vertebral arteries in accordance with yet another exemplaryembodiment.

FIG. 19 is an example of a schematic view of a device for vertebralcompression, similar to the device depicted on FIG. 18 , but carryingfeatures of an additional exemplary embodiment.

FIG. 20 is an example of a cross-sectional view of a neck of a patientand a device of FIGS. 18 and 19 for selective compression of vertebralarteries attached thereto in an actuated state with an option of arestrictive pad at an external surface of a compression member.

FIG. 21A is an example of a front view of a patient with a compressiondevice in accordance with another exemplary embodiment.

FIG. 21B is an example of a cross-sectional view of a neck of a patientand a device of FIG. 21A attached thereto in an actuated state when bothcarotid and vertebral arteries are compressed.

FIG. 22 is an example of a front view of a patient with anotherembodiment of the compression device, designed for selective compressionof carotid arteries.

FIG. 23A is an example of a cross-sectional view of a neck of a patientand a device of FIG. 22 attached thereto in an actuated state withselective compression of carotid, but not vertebral arteries.

FIG. 23B is an example of a cross-sectional view of the device of FIG.23A in a unactuated state.

FIG. 23C is an example of a cross-sectional view of the device of FIG.23A in an actuated state.

FIG. 23D is an example of a schematic view of the device of FIGS. 23A,23B and 23C.

FIG. 24A is an example of a front view of a patient with yet anotherembodiment of the antiembolic compression device.

FIG. 24B is an example of a cross-sectional view of the device of FIG.24A in a partially unactuated state.

FIG. 24C is an example of a cross-sectional view of the device of FIG.24A in a fully actuated state.

FIG. 24D is an example of a schematic view of the device of FIG. 24A.

FIG. 24E is an example of a compression device.

FIG. 25 illustrates an example of a compression member having a coniccross-sectional shape.

FIG. 26 illustrates an example of a compression member having an arcuatecross-sectional shape in combination with another compression member,such as a compression member with a cross-sectional shape that is aconic shape, oval shape, or pear shape.

FIG. 27 illustrates an example of a compression member having a pearcross-sectional shape.

FIG. 28 illustrates an example of a compression member having a crescentcross-sectional shape in combination with another compression member,such as a compression member with a cross-sectional shape that is aconic shape, oval shape, or pear shape.

FIG. 29 illustrates an example of a compression member having a singlefinger cross-sectional shape with a tip aimed at a target artery.

FIG. 30 illustrates an example of a compression member having a multiplefinger cross-sectional shape with tips aimed at a target artery.

FIG. 31 illustrates an example of a compression member with a bilobarcross-sectional shape.

FIG. 32 illustrates an example of a self-centering andstructure-spreading effect of a compression member with a coniccross-sectional shape leading to selective compression of an arterywhile self-positioning between surrounding structures and conforming tothe anatomy of a neck triangle.

FIG. 33 illustrates an example of an inter-carotid distance.

FIG. 34 illustrates an example of carotid bridging.

FIG. 35 illustrates an example of a tracheal hinge.

FIG. 36 illustrates an example of a range of angles of crossing of thecourse of a target blood vessel by a compression member in relation to alongitudinal axis of a target vessel.

FIG. 37A illustrates an example of compression members of differentcross-sectional shapes and size as a part of an example compression kit.

FIG. 37B illustrates an example of an adjustable neck collar forcompression of extracranial cerebral arteries as a part of an examplecompression kit.

FIG. 37C illustrates an example of neck sizing templates for measuringthe distance between arteries of a patient as a part of an examplecompression kit.

FIG. 38 is an example block diagram illustrating a system of the subjecttechnology.

FIG. 39 is an example diagram illustrating modules implementing methodsof the subject technology.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

In the following detailed description, specific details are set forth toprovide an understanding of the subject technology. It will be apparent,however, to one ordinarily skilled in the art that the subjecttechnology may be practiced without some of these specific details. Inother instances, well-known structures and techniques have not beenshown in detail so as not to obscure the subject technology.

The subject technology relates to prevention of emboli and ischemicinjury (such as ischemia and stroke) as a consequence of an emboligenicevent and/or intervention, e.g., on the heart, heart valves, coronaryarteries and aorta. The subject technology provides for a device forsafe and effective compression of a blood vessel, such as a carotidand/or vertebral artery, by providing one or more compression membershaving an anatomically congruent cross-sectional shape, size, and/orconfiguration. The subject technology also provides for a device forcompression of a blood vessel, such as a carotid and/or vertebralartery, that has one or more compression members that areself-adjustable and allow precise positioning in an anatomical groovewhere a vessel, such as an artery, is located. The subject technologyalso provides a method of preventing arterial embolization by divertingemboli from a circulation to be protected, such, as cerebralcirculation, arm circulation, leg circulation or else.

Reference will now be made in detail to example embodiments of thesubject technology, one or more examples of which are illustrated in thedrawings. Each example is provided by way of explanation of the subjecttechnology, and not meant as a limitation of the subject technology. Forexample, features illustrated or described as part of one embodiment canbe used with another embodiment to yield still a third embodiment. It isintended that the present subject technology include these and othermodifications and variations.

It is to be understood that the ranges mentioned herein include allranges located within the prescribed range. As such, all rangesmentioned herein include all sub-ranges included in the mentionedranges. For instance, a range from 100-200 also includes ranges from110-150, 170-190, and 153-162. Further, all limits mentioned hereininclude all other limits included in the mentioned limits. For instance,a limit of up to 7 also includes a limit of up to 5, up to 3, and up to4.5.

The subject technology provides for a device for safe and effectivecompression of a blood vessel, such as a carotid and/or vertebralartery, by providing one or more compression members having ananatomically congruent cross-sectional shape. The subject technologyalso provides for a device for compression of a blood vessel, such as acarotid and/or vertebral artery, that has one or more compressionmembers that are self-adjustable and allow precise positioning in ananatomical groove where a vessel, such as an artery, is located. Thesubject technology also provides a method of preventing arterialembolization by diverting emboli from a circulation to be protected,such as cerebral circulation, arm circulation, leg circulation or else.

In some embodiments, the one or more compression members of the devicecan have a cross-sectional shape and/or size based on a specificlocation of an artery in a neck, such as in a neck triangle and/or in agroove between a trachea and/or longus colli muscle medially and amuscle, such as a sternocleidomastoid or scalenus anterior muscle,laterally. By using different cross-sectional shapes and/or sizes ofcompression members, the members can be actuated so as to enter a groovein the neck and effectively reach a blood vessel, such as an artery, tobe compressed. As a result, selective compression of a blood vessel,such as an artery, can be achieved without compromising adjacent organsin the neck, such as a trachea. Such specifically configured actuationand compression helps to assure safety when compressing a blood vessel,such as a carotid and/or vertebral artery, and prevents atheroscleroticplaque from dislodging and inducing stroke.

With reference to FIG. 1 , a schematic view of a branching vessel suchan aortic arch is shown in which emboli 8 are transferred from the moreproximal arterial trunk 1, such an ascending aorta, into more distalbranches 2 and 3, such as carotid 16, vertebral 12, or subclavian 13arteries causing ischemic injury to the organ they supply (such asstroke in the case of embolization of cerebral arteries).

FIG. 1 shows a hypothetical blood vessel 1 branching into the bloodvessels 2 and 3. The antegrade flow 5 in the vessel 1 carries blood,containing emboligenic particles 8 to different areas in the human body,including an organ more vulnerable to ischemic injury (such as a brain,and in some embodiments, a lung or extremity)—via the blood vessel 3,and less vulnerable (such as soft tissues of less important areas)—viablood vessel 2. As shown in FIG. 1 , the emboli 8 entering vessel 1 willfollow the path of branching into the vessels 2 and 3 and will enterboth vessels 2 and 3 proportionally to the magnitude of flow throughthese vessels. The more flow would occur via the blood vessel 2, themore emboli will enter the organ to be protected (such as a brain)leading to serious ischemic injury (such as stroke).

To protect an organ (such as a brain) from embolization and ischemicinjury (such as stroke), it is important to deflect emboli from theorgan. Multiple invasive techniques have been attempted to deflectemboli from an organ at risk. For example, deflection of emboli has beenattempted using intravascular traps, filters, and deflectors. Thesedevices, besides being very complicated, involve introduction ofadditional hardware into a patient's circulation with unavoidable traumato the vessel wall, disturbance of atherosclerotic plaque, and furtherembolization and stroke.

This can be avoided by external compression of the blood vesselssupplying the organ at risk. Multiple devices for external compressionof arteries of extremities of a human have been created, all of whichare based on the general principle of a tourniquet or a diffuse pressureprinciple. However, this inevitably leads to compression of not only theartery, but also the tissues and organs surrounding the artery. As aresult, these devices are not suitable for compression of the carotidand vertebral arteries due to the unique anatomy of the human neck,where the arteries are located deeply in anatomical grooves where theyare difficult to reach. Moreover, these arteries are surrounded bymultiple vital structures, such as the trachea, esophagus, brachialplexus, jugular vein, and cervical spine. Uniform nonspecific circularor other wide area compression of the structures of the neck can lead toserious organ injury and death, or other complications such as asphyxia,trauma to the tracheal cartilages, and/or compromise of the tracheallumen without achieving a desired amount of carotid compression. If ahigh pressure is applied to overcome the resistance of the structures ofthe neck and compress the carotid and/or vertebral arteries in theiranatomical grooves, there is a high risk of injury to the carotid and/orvertebral arteries with potential intravascular thrombosis, emboli andstroke, compression of jugular veins with brain edema, trauma to thetrachea, and other drastic complications.

Examples of devices and methods for diverting emboli from circulation ina patient are described in U.S. patent application Ser. No. 11/859,235,which published as U.S. Patent Application Publication No. 2013/0304111,U.S. patent application Ser. No. 14/261,565, which published as U.S.Patent Application Publication No. 2014/0236221, and U.S. patentapplication Ser. No. 14/703,669, which published as U.S. PatentApplication Publication No. 2015/0313607, each of the disclosures ofwhich are hereby incorporated by reference herein in their entireties.

The device, method, and system disclosed herein provide a way ofovercoming the aforementioned problems by providing anatomically sound,controlled, and brief compression of a blood vessel, such as a carotidand/or vertebral artery, while avoiding compression of the surroundingstructures in the neck, such as the trachea, jugular veins, esophagus,brachial plexus, and spine. For example, a device with a set ofcompression members can provide for compression of carotid and/orvertebral arteries while avoiding compression of surrounding structuresof the neck. A compression member, or a combination of compressionmembers, can be have a cross-sectional shape and/or size for aparticular neck anatomy. Thus, individual anatomic variations betweenpatients can be accounted for, and a particular device and/orcompression member(s) may be selected for use on a particular patient.Compression of the compression member(s) may cause the compressionmember(s) to self-center, spread tissue(s), and/or spare tissue(s) fromcompression and largely limit the area of compression to the carotidand/or vertebral artery.

Additionally, a method and system of using the device is provided, thatinduces temporary noninvasive external compression of the blood vesselssupplying the organs at risk for embolic damage. The device can beactuated at a moment of emboligenic intervention and may be triggeredand deactivated on demand and automatically on the basis of a patient'sphysiological parameters and/or detection of emboligenic particles.

External compression may create a pressure gradient inside the bloodvessel that precludes transgression of embolic particles into theparticular vessel, and protects the organ that is supplied by thevessel. As illustrated in FIG. 13 , bilateral compression of carotidand/or vertebral arteries at moments of embolic washout triggered duringa cardiovascular procedure may protect the brain from incoming embolicparticles by deflecting the particles into other, less vulnerable, areasof the human body.

FIGS. 2-7 show examples of a disclosed method of diverging emboli 8 fromimportant structures such as a brain by exerting external pressure 10 onthe blood vessel 3 (such as carotid or vertebral artery) to create anarea of the pressure gradient 9 leading to limitation of the blood flow5 carrying emboli 8 to the compressed blood vessel 3. Such compressionwill lead to flow reversal 7 diverting emboli 8 into other lessimportant vessel 2. Acceleration of flow via the blood vessel 2 whilethe blood vessel 3 is compressed according to Bernoulli's principle willprovide an additional force 7 deflecting the emboli 8 from the vessel 3into the vessel 2. In order to avoid prolonged limitation of flow to themost important area of the human body (such as brain) the time of theprotective compression of the blood vessel 2 should be brief. This goalis achieved by a disclosed method of vascular compression “on demand”,i.e. at the brief periods of time when the emboligenic particles arereleased. As shown in FIGS. 3-7 the detectors of emboli “A” and/or “E”can be placed over the source of emboli (such as heart, heart valve,aorta, etc.) or the blood vessels 1 and 3, carrying said emboli to thetarget organ (such as brain). The appearance of emboli in said areaswhen detected as echogenic signal or as another physiologicalparameter(s), reflecting cardiac ejection and systole (such as EKG,arterial Doppler, pulse oximetry, arterial waveform etc.) will berecorded by monitor “B” and will actuate the compression mechanism “C”that would temporarily compress the blood vessel 3 leading tolimitation, interruption and/or reversal of the flow to the organ to beprotected. Detection can occur during and be sensitive to flight ofemboli or other debris in transit within a blood vessel. The length ofcompression and its intensity will be recorded by monitoring system “D”with a capacity of overruling the act of compression if its length orintensity exceed the safe limit. Thus, positive and negative feedbackmechanisms will be assured with a potential for an automatedauto-regulatory function of such a device.

Once the emboli 8 disappear from the inflow vessel 1 and/or deflectedfrom the blood vessel 3 into the blood vessel 2, the detectors “A”and/or “E” will signal such events to the device “B”, that in turn willprovide negative feedback to the device “C” thus interrupting the act ofcompression 10 and restoring circulation via the blood vessel 3 to theorgan to be protected (such as brain). Considering the fact that themajority of embolic events leading to the organ damage and stroke incardiovascular procedures are very short, this method and system arefeasible and reliable, thus providing anti-embolic protection at themoments of surgery when the risk of embolism is maximal, while restoringcirculation to such organs when the risk of embolism is minimal. Theprocess of vascular compression alternating with vascular release can berepeated on multiple occasions throughout the course of cardiovascularprocedure or a cardiac cycle.

FIG. 8 illustrates a front view of a patient with embolic particles inthe heart and ascending thoracic aorta with potential for propagationinto both carotid arteries 16 and other blood vessels, such as vertebralarteries 12. The source, of the emboli may be, for example, a diseasedaorta, aortic valve 15, and/or heart 11.

The emboli 8 (FIG. 1 ) may be fragments, of atherosclerotic plaque 19(FIGS. 8, 9 ) of the ascending thoracic aorta that become dislodgedduring surgical or catheter manipulations on the aorta. Also shown inFIGS. 8 and 9 is calcification of the aortic valve 15 and intra-cardiacembolic particles 20 of the heart 11 that can also be the origin ofemboli 17 eventually present in any artery such as the carotid artery 16or vertebral artery 12. The intra-cardiac emboli 20 may include air,gas, thrombi and atherosclerotic materials. Although all of the variousemboli in the heart 11, aorta and aortic valve 15 need not be present inall instances, they are all shown in FIGS. 8 and 9 for sake of example.Trauma to the heart 11, aortic valve 15 and aortic structures duringplacement and removal of items such as an aortic clamp, guidewire,catheter, balloon and/or an electrophysiological instrument can giverise to the presence of emboli 17 in the carotid arteries 16, vertebralarteries 12, and/or subclavian arteries 13. Additionally, a manipulationsuch as coronary artery bypass grafting, aortic and mitral valvereplacement, catheter ablation, endovascular grafting of the aorta,percutaneous implantation of the aortic or mitral valves, endovascularmanipulations on the aorta, aortic branches and the heart 11 may giverise to the presence of emboli 17 in the carotid arteries 16, vertebralarteries 12, and/or subclavian arteries 13. Critical moments of theaforementioned procedures (for example, during the aortic cross clampmanipulation, aortic valvuloplasty or valve implantation, coronaryinterventions, and/or endovascular procedures on the aorta) may causeemboli 17 to form and cause stroke and are referred to as emboligenicevents.

The device, method, and system disclosed herein can also be applied forprevention of venous and/or pulmonary artery emboli. In this case thedetection of the moving venous thrombus/embolus traveling from theperipheral vein toward the heart and pulmonary artery may initiate themeasures for prevention of embolism by virtue of compression of theveins on its path, and signaling and initiating of other measures ofprophylaxis of pulmonary embolism if necessary (such as deployment ofthe embolic trap or, starting thrombolytic therapy). The detection of amoving thrombus/embolus can be achieved using a vascular Dopplertechnique, echocardiography or other methods.

A device, such as one of the example devices depicted in FIGS. 13-24 ,may be placed around the part of the body containing the target vesselthat is noninvasive and can include a vascular compression member(s) 27and/or 27-V applied to an area of an artery at a certain angle (rangingfrom 0 to 90) to an axis of the artery. The device may comprise atransverse vascular compression member 32. The members 27, 27-V and 32can be converted from an unactuated state to an actuated state in whichthe members 27, 27-V and 32 create an area of compression 23 and 23-V atthe target arteries such as carotid (16), vertebral (12), subclavian(13) or femoral or any other hypothetical vessel 2 to limit blood flowtherethrough into the circulation to be protected such as cerebral orany other circulation. The members may have a particular shape and/orsize, such as any of the shapes disclosed with reference to FIGS. 23-32,35, and 37A. Emboli 8, 17, 18, 20 that are formed in the patientsecondary to emboligenic intervention are diverted into a descendingaorta 14 and other less important vascular structures.

As shown in FIG. 9 the emboligenic particles 18 and 20, formed in theheart 11, aortic valve 15 and aorta may enter the carotid arteries 16and vertebral arteries 12, thus becoming cerebral emboli 17 leading toobstruction of cerebral circulation and stroke. As shown in FIG. 10 ,the degree of embolization may significantly increase at the time ofcardiac contraction (systole) when intra-cardiac (20) and aortic (18)particles are forcefully ejected into the systemic circulation, leadingto a massive entry of emboli 17 into the carotid 16 and vertebral 13arteries. With respect to the method of anti-embolic protectiondisclosed above it is feasible to protect cerebral circulation byapplying temporary pressure on the carotid and, if needed, vertebralarteries for a brief period of time when the risk of embolization ismaximal (FIG. 11 ). Using detectors of potential emboligenic particlesand emboli in the heart and aorta (by ECHO), aorta and, its branches (asassessed by Doppler ultrasound) with timely signaling and immediateinitiation of the protective compression of the target blood vesselssuch as carotid arteries 16 and/or vertebral arteries 12 will lead totemporary limitation of the blood inflow such as carotid and/orvertebral flow, thus protecting the organ, such as brain, from embolicload. Upon creation of the areas of vascular compression 23 (carotid)and 23-V (vertebral), a relative pressure gradient and a “no-flow” or“low-flow” condition is produced in the proximal segments of thecompressed arteries such as carotid 16 and vertebral 12 arteries thatprevents emboli 18 from entering the circulation to be protected such ascerebral circulation. The proximal carotid 16 and vertebral 12 arteriesare areas of said arteries upstream from the areas of compression 23 and23-V that have interrupted or diminished blood flow due to thecompression. Potential cerebral vascular emboli such as emboli 18 arediverted into the more distal vessels such as descending aorta 14 andare illustrated as emboli 21. The thin arrow at the level of aortic archon FIG. 11 shows preferential direction of the blood flow that carriespotential emboli such as cerebral emboli 17 into the descending aorta 14when the areas of compression 23 and 23-V are created. To protect thebrain from an augmented embolic load at the time of cardiac systole(FIGS. 12 and 13 ) a method of carotid 16 and/or vertebral 12compression synchronized with systolic phase of cardiac activity isdisclosed. The compression system 49 (box C in FIG. 7 ) is actuated anddeactuated by the device 58 (Box B in FIG. 7 ) depending on the phase ofcardiac activity. Thus, the timing, of the vascular compression 23 and23-V in order to limit the inflow of emboli 17 can be triggered byelectrophysiological, hemodynamic and/or pulse-oximetric indices ofcardiac contraction, received and processed by the detector 58. On theother hand, the deactuation of the compression in order to restorearterial perfusion to the brain may be triggered by the same indices,but in the phase of cardiac relaxation.

FIGS. 13-16 disclose an exemplary embodiment that can selectively limitflow to either carotid 16 or vertebral arteries 12, or if necessary,limit flow to all or any combination of these vessels. Said device canbe used to create the areas of compression 23 and 23-V as previouslydescribed to deflect emboli 18 and 20 from the target arteries such ascarotid arteries 16 and vertebral arteries 13. The goal of thiscompression is to prevent the entry of emboli in the circulation to beprotected such as cerebral circulation. The device can be positioned onthe neck of the patient so that a pair of straps 33 and 43 extend aroundthe neck of the patient and are secured to one another via hooks 44 andloops 45 that form a hook and loop type arrangement. However, it is tobe understood that other mechanisms of securing the straps 33 and 43 toone another are possible and that the disclosed arrangement is only oneexemplary embodiment. Securement of the hooks 44 and loops 45 causes thedevice 26 to be retained onto the body part such as the neck of thepatient. This retention may be loose so that the device 26 has some roomto give on the body part such as the neck, or the retention may be of atightness that firmly secures the device into the body part such as theneck and prevents same from moving or twisting. The compression devicemay be a neck collar 26, combination of compression elements, bars,levers, pads, inserts and screws to provide compression of the targetvessel in accordance with various exemplary embodiments. In otherarrangements the compression device 26 may be a strap that lays on thefront of the body part to be protected such as the neck of the patient,or may be made of multiple components that are not directly attached toone another but are positioned proximate to the neck of the patient. Thedevice 26 may include two semi-oval halves that may be positioned aroundbody part of the patient such as the neck or extremity of the patient inaccordance with one exemplary embodiment. The device 26 need not becircular in cross-sectional shape. Even if the device 26 is not circularin cross-sectional shape it may still have a central axis 56 (FIG. 23A)as the central axis 56 can be located at the center of the vessel andthe body part to be protected such as a carotid artery and the neck ofthe patient and thus may still be a central axis 56 of the device 26.

With reference in particular to FIGS. 23B, 23C and 23D, a pair ofinsertion pockets 41 and 42 are present on the device 26 and may besealed at their tops and bottoms with respect to the vertical direction55. As used herein, the vertical direction 55 may be the direction ofthe device 26 that is parallel to the direction of extension of thecentral axis 56. Strap 33 may extend from the first insertion pocket 41,and strap may extend from the second insertion pocket 42. The firstinsertion pocket 41 forms a cavity into which a first vascularcompression member 27 is located. Member 27 is shown in a relaxed orunactuated state in FIG. 23B and may be made of a flexible material thatcan be stretched or otherwise deformed. A member 27 may be a compressionmember, such as any of the compression members described with referenceto FIGS. 23-32, 35, and 37A. The material making up member 27 can benonporous such that member 27 is capable of being filled with gas orliquid that enables the member 27 to expand and at the same time holdthe gas or liquid therein. The member 27 may have a particular shapeand/or size before and/or after being expanded. The pocket 41 may bemade of a material that is different than the material making up member27.

The second insertion pocket 42 forms a cavity into which the secondvascular compression member 46 is retained. Member 46 may be configuredin a manner similar to member 27 and a repeat of this information is notnecessary. Member 46 may be completely sealed or connected to an openingthat leads into connecting tube 54. Member 46 is in an unactuated statein FIG. 23B. Similarly, for compression of vertebral arteries 13 twoinsertion pockets 41-V and 42-V may be created. Said pockets may containcompression members 27-V and 46-V and other components to facilitatearterial compression as described in previous paragraphs. If necessary,only vertebral compression members can be actuated (FIG. 17 ). Thespecific anatomic location of the vertebral compression members isdisclosed and should correspond to the level of the C4-C7 vertebra inorder to assure adequate compression of the vertebral arteries 13against the body of C-7 and in between the longus colli muscle mediallyand scalenus anterior and sternocleidomastoid muscle laterally (FIGS. 16and 20 ). In other embodiments, however, only the carotid (FIGS. 22 and23A) or, conversely, only vertebral (FIGS. 18-20 ) compression memberscould be present. Other arrangements and combinations of compressionmembers are possible in order to achieve selective compression of anycombination of the carotid and vertebral arteries. Some of theseembodiments are shown on FIGS. 13-32, 35, and 37A.

A pressure or compression source 49 may be included and may be placedinto communication with the first vascular compression member 27 by theway of tubing 29 that extends through a port of member 27. A manometer30 may be included in the device 26 at some point between the member 27and the pressure/compression source 49 in order to monitor and measurepressure in the system. A detector of emboli and/or EKG, pulse oximeter,arterial waveform monitor 58 can be bundled with the pressure source 49to assure an option of initiation of the vascular compression once thepotential emboli are ejected or anticipated. FIGS. 23C and 23Dillustrate the device 26 once the pressure/compression source 49 isactivated in order to cause the device 26 to be pressurized. Thepressure source 49 may be a pump that injects air, gas or liquid, suchas water, through the pressure tubing 29. Injection of air or otherwiseincreasing the pressure causes the first vascular compression member 27to expand. Due to fluid communication through the connecting tube 54,the second vascular compression member 46 will likewise expand and thetwo members 27 and 46 may expand at the same rate to the same size.Expansion may be in the radial direction 57 such that the expandablemembers 27 and 46 expand towards the central axis 56 and away from thecentral axis 56. In some exemplary embodiments, the members 27 and 46may expand in the radial direction 57 towards the central axis 56 butnot in the radial direction 57 away from the central axis 56. Thisarrangement may be accomplished by making portions of the compressionmembers 27 and 46, for example the portions facing away from the centralaxis 56 in the radial direction 57, such that they cannot expand whilethe portion facing towards the central axis 56 are in fact expandable.Said arrangements can be also applied to the vertebral compressionelements 41-V, 42-V, 46-V and 27-V and their repetition of them is notnecessary.

The compression members 27 and 46 as well as 27-V and 46-V may beinflated to a pressure level that is, just above the level of thepatient's arterial pressure to achieve temporary limitation orinterruption of the arterial blood flow. The arteries to be protectedsuch as both the left and right carotid arteries 16, left and rightvertebral arteries 12, and if needed, femoral and brachial arteries canbe compressed at the same time or separately and in any combination.

Additionally or alternatively, the insertion pockets 41, 42 and 41-V,42-V could have portions that are made of different materials so thatthe parts facing the central axis 56 in the radial direction 57 areexpandable while the parts facing away from the central axis 56 in theradial direction 57 are not expandable. The compression members 27, 27-Vand 46, 46-V are elongated in the vertical direction 55, which is thesame direction as the central axis 56. However, it may be the case thatupon expansion of the expandable members 27, 27-V and 46, 46-V from theunactuated to the actuated states the expandable members 27, 27-V and46, 46-V do not expand in the vertical direction 55. Moreover thecompression members may not be expandable at all and may exertcompression into the underlying vascular structure by virtue oftightening of their attachment apparatus or external straps.

The exemplary embodiment of the device 26 in FIGS. 23A-23D does notinclude a transverse vascular compression member 32 but instead includesonly two compression members 46 that can be expandable. The device 26may be placed onto the patient so that the first longitudinalcompression member 27 overlays the artery to be protected such as acarotid artery 16, or both carotid and vertebral artery 12 (FIGS. 21Aand 21B) such that the artery is located between the central axis 56 andthe member 27 in the radial direction 57. However, other arteries suchas subclavian, or femoral and brachial artery can be compressed in asimilar manner. If needed second vascular compression member 46 and 46-Vmay be laid on top of the other artery such as carotid artery 16 andvertebral artery 12, such that the second artery is likewise between themember 46 and 46-V and the central axis 56 in the radial direction 57.Expansion forces of the expandable members 27 and 46 and 27-V, 46-V orthe outer compression forces on non-expandable or partially expandablemembers 27, 27-V and 46, 46-V may be imparted onto the target arteriessuch as carotid arteries 16 and vertebral arteries 12 so that they arecompressed thus forming the areas of compression 23 and 23-V aspreviously discussed. The pressure at the compression members 27, 27-Vand 46, 46-V may be set so as to exceed the patients systemic pressureto achieve adequate compression of the carotid arteries 16 and vertebralarteries 12 to have a transient “no-flow” or “low-flow” effect. In somearrangements the pressure of the members 27, 27-V, 32 and/or 46, 46-Vmay exceed the patients systemic pressure by 10-20 mm Hg, or up to 30 mmHg and even higher in accordance with certain exemplary embodiments.Once the emboligenic part of the procedure is completed, the pressure inmembers 27 and 46 may be released in order to establish adequatearterial flow, such as carotid, brachial or femoral arterial flow. Therelease of pressure can also be triggered by disappearance of embolicparticles in the heart chambers (as detected by cardiac ECHO), aorta (asdetected by arterial Doppler), carotid and cerebral arteries (asdetected by carotid Doppler ultrasound and transcranial Doppler) and bythe indices of cardiac relaxation (diastole) as reflected by EKG, pulseoximetry, arterial pressure waveform and other indices.

An automated self-regulating compression-relaxation mechanism or systemis thus possible, allowing for real-time monitoring and anti-embolicprotection during cardiovascular interventions. Such mechanism or systemwould include the elements A, B, C, D and E as depicted in FIGS. 1-6with a feature of a fully automated vascular compression-relaxationdepending on the embolic load and the phase of cardiac cycle.

Another exemplary embodiment of the device 26 is illustrated in FIGS.24A-24D. The device 26 in this exemplary embodiment also functions tocompress the carotid arteries 16 to create the areas of compression 23.The device 26 includes a first insertion pocket 41 and a secondinsertion pocket 42 but lacks first and second vascular compressionmembers 27 and 46. Instead a first compression member 52 is locatedwithin the first insertion pocket 41, and a second compression member 53is located within the second insertion pocket 42. The compressionmembers 52 and 53 are not expandable but may be made of a material, suchas foam, that can be compressed and then can subsequently expand backinto its original shape. The compression members 52 and 53 mayalternatively be made of a material that does not exhibit any give uponthe application of forces thereto that would be encountered in aprocedure of the type described herein. The compression members 52 and53 may be elongated in the vertical direction 55 and may have a convexshape that faces the central axis 56. The shape of the compressionmembers 52 and 53 at their surfaces that face away from the central axis56 in the radial direction 57 may be different than those that facetowards the central axis 56. In some embodiments, the compressionmembers may have a cross-sectional shape and/or size that corresponds toany of the compression members illustrated in FIG. 24, 25-32, 35 , or37A.

The device 26 may include a transverse carotid compression section 31that is located outward from the compression members 52 and 53 in theradial direction 57 from the central axis 56. A transverse carotidexpandable member 32 may be held by the section 31 and can have an arclength about the central axis 56 that extends beyond both of thecompression members 52 and 53. The transverse carotid expandable member32 has a height in the vertical direction 55 that is the same as, largeror smaller than the height of the compression members 52 and 53 in thevertical direction 55. The member 32 is made of a material that willhold air, gas or liquid such that it can be expanded upon theapplication of fluid thereto. The member 32 has a single port that is influid communication with the pressure tubing 29. Application of pressureto the member 32 will cause the member 32 to expand as shown for examplein FIGS. 24C and 24D. In some embodiments the member 32 can be partiallyor completely deflated, removed and not present so that only theexpandable members 27, 32 and/or members 52 and 53 are present tocompress the carotid arteries 16 and/or vertebral arteries 12. In otherembodiments, the compression members 52 and 53 can be removed and notpresent so that only the expandable member 32 is present to compress thecarotid arteries 16.

The transverse carotid compression section 31 can be arranged so thatall of it is expandable or so that only a portion of it expands as themember 32 expands. Boundary lines 50 and 51 may demarcate areas of thetransverse carotid compression section 31 that can expand from thosethat cannot expand. For example, the portion of section 31 radiallyoutward from the boundary lines 50 and 51 may not be capable ofexpansion while the portions of section 31 radially inward from boundarylines 50 and 51 are capable of stretching and thus expanding orcontracting. This arrangement may cause expansion only, or primarily, inthe radially inward direction upon expansion of the expandable member32. In other embodiments, the section 31 is made of the same materialand exhibits expansibility such that it generally expands in alldirections equally. The expandable member 32 may be arranged so that itdoes not lengthen in the vertical direction 55 upon expansion, or insome arrangements only minimally expands in the vertical direction 55when actuated.

Placement of the device 26 onto the patient may result in the firstcompression member 52 overlaying the target artery such as carotidartery 16 femoral or brachial artery so that the artery to be compressedis between compression member 52 and the central axis 56 in the radialdirection 57. The second compression member 52 will be arranged so thatit overlays the second carotid artery 16 causing it to be between thesecond compression member 52 and the central axis 56 in the radialdirection 57. The expandable members 27, 32 and 46 may be located at theneck, upper chest, shoulder, lower abdomen or an extremity of thepatient such that they are secured to the neck or extremity or otherwiseproximate. The compression members 27, 32 and 46 need not be in directcontact with the body part of the patient such as the neck, chest,abdomen or extremity but only located near them. Application of pressurevia the pressure source 49 causes the transverse compression member 32that may be expandable to exert pressure in the radial direction 57.This inward radial pressure causes the compression members 52 and 53 tomove inwards and be urged against the target vessels such as carotidarteries 16, femoral, brachial or other compressible arteries or veins.The positioning and configuration of the members 52 and 53 function toimpart compressive forces onto the arteries to be compressed such ascarotid arteries 16, femoral, brachial or other arteries when the device26 is pressurized thus resulting in the creation of the areas ofcompression 23. The other components of the device 26 may be made asthose previously described and a repeat of this information is notnecessary.

Although described as lacking first and second longitudinal vascularcompression members 27 and 46, an alternative arrangement may be made inwhich these members 27 and 46 are present. In such an arrangement, theexpandable members 27 and 46 may expand in order to press thecompression members 52 and 53 towards the arteries to be compressed suchas carotid arteries 16, femoral, brachial or other compressiblearteries.

Moreover, it can also be arranged for compression of the vertebralarteries 12, or both vertebral 12 and carotid 316 arteries by addingadditional compression members in the same arrangement as describedabove.

Another exemplary embodiment of the device 26 is one in, which a pair oflongitudinal vascular compression members 27 and 46 are present alongwith a transverse vascular compression member 32. A pair of compressionmembers 52 and 53 may be missing from this embodiment, or they may bepresent in certain arrangements. This exemplary embodiment may includeadditional pressure tube lines 47 and 48 that are separate from pressuretubing 29 that actuates the transverse vascular compression member suchas carotid compression member 32. Pressure tube lines 47 and 48 providepressure to the first and second longitudinal vascular compressionmembers 27 and 46 so that these members 27 and 46 can be actuated atdifferent rates, amounts, and/or times than compression member 32. Thisflexibility provides selective pressure adjustments between thetransverse vascular compression member 32 and longitudinal vascularcompression members such as carotid members 27 and 46. This feature willprovide an option to decrease or completely eliminate the degree ofcircumferential compression of the body part such as the neck orextremity when selective inflation of the longitudinal vascularcompression members is adequate. Conversely, if inflation oflongitudinal compression members such as carotid members 27 and 46 doesnot lead to sufficient reduction of the arterial flow, an additionalinflation of the transverse vascular compression member such as carotidmember 32 would allow one to achieve the desired effect by combining theeffect of pressure created in all of the members described.

The preferred method of an arterial compression in this case, forexample—compression of the carotid and vertebral arteries, will be, aninitial inflation of longitudinal members 27 and 46, followed byinflation of member 32 when necessary. The degree of interruption of thearterial flow in this and other embodiments can be checked by the dataof arterial Doppler, distal pulsation and oximetry as wells as othertechniques of assessment of distal perfusion. The other components ofthe device 26 are the same as those previously disclosed with respect toother embodiments and a repeat of this information is not necessary.

An alternative exemplary embodiment of the device 26 that is beingdisclosed is similar to that previously disclosed with respect to FIGS.23 and 24A-D and a repeat of the features and functionality that are,similar between the two need not be repeated. The pressurization of themembers 27, 32 and 46 are different in that the second pressure tube 47feeds into the first longitudinal vascular compression member 27, and inthat the third pressure tube 48 supplies the second longitudinalvascular compression member 46 to allow the members 27 and 46 to bepressurized independently from one another. In this regard, one canapply more or less pressure to member 27 than member 46 so thatcompression of the arteries, such as carotid arteries 16 or femoral andbrachial arteries can be more precisely controlled. The transversevascular compression member 32 is supplied by pressure tubing 29 and isindependent from the expansion of members 27 and 46 such that it can bepressurized to a greater or lesser extent than members 27 and 46. Themanometer 30 may be capable of measuring pressures in all of the lines29, 47 and 48 so that their individual pressures can be monitored. Inuse, one may adjust the pressures in members 27 and 46 first, thensubsequently if needed one may apply pressure into member 32 to causeits actuation so that adequate compression of the carotid arteries 16 isrealized. In some instances, however, member 32 can be partially orcompletely deflated, removed and not present.

The ports for the pressure lines 47 and 48 may be located at the bottomof the expandable members 27 and 46 in the vertical direction 55.However, the ports for pressure lines 47 and 48 need not be in thedisclosed locations in accordance with other exemplary embodiments andmay be above the transverse carotid compression section 31 or at thesame location as the section 31 in the vertical direction 55 in otherexemplary embodiments. The insertion pockets 41 and 42 althoughdescribed as being sealed may have an opening into which the expandablemembers 27 and 46 may be removed and into which first and/or secondcompression members 52 and 53 may be inserted so that the device 26 canfunction with the compression members 52 and 53 and transverse carotidexpandable member 32 as previously discussed.

The arrangement of the device 26 in this case includes a pair oflongitudinal vascular compression members 27 and 46 along with atransverse vascular compression member 32. The circumferential distanceabout the central axis 56 may be the circumferential distance about theneck or extremity of the patient when the device 26 is worn by a patientand thus these two terms can be interchangeable when discussing the arclength of the member 32. In other exemplary embodiments, the arc lengthof the member 32 may be from 50-65% (180 degrees-234 degrees) about thecircumference of the body part of the patient, from 25%-50% (90degrees-180 degrees) about the circumference of the body part patient,or from 15%-25% (54 degrees-90 degrees) about the circumference of thebody part of the patient. In yet other exemplary embodiments, the member32 may extend 360 degrees completely about the body part of the patient.

The longitudinal vascular compression member such as carotid compressionmembers 27 and 46 are closer to the central axis 56 in the radialdirection 57 than the transverse compression member 32 is to the centralaxis 56. Comparison of FIG. 6C and, using a device for compression ofthe carotid arteries as an example, demonstrates that the lengths of themembers 27, 32 and 46 do not increase in the vertical direction 55, orin the arc length direction, upon moving from the unactuated orientationto the actuated orientation or only slightly expand in these directionsupon actuation. The majority of the expansion may be in the radialdirection 57 either towards the central axis 56 or away from the centralaxis 56 or a combination of the two. In other arrangements, however,expansion of the members 27, 32 and 46 may result in equal expansion inall directions. As previously stated, various components of the device26 may be arranged and function in a manner similar to those aspreviously discussed and a repeat of this information is not necessary.

FIG. 24E discloses an example embodiment of a compression device 105 inaccordance with the disclosure herein. As illustrated in FIG. 24E, acompression device (e.g., compression neck collar) may be narrower(e.g., a distance. A 110) in front of a trachea 34 (e.g., in front ofthe neck) of the patient and wider (e.g., a distance B 115) over an areaoverlapping the carotid arteries 16 (e.g., over lateral aspects of theneck) of the patient. In some embodiments, a compression device arrangedin this manner may be a better fit for a patient having a short neckwhile leaving a wider area of the upper anterior chest and sternumexposed in order to facilitate sterile access to the patient's sternumin heart surgery in such a way that the vertical (longitudinal)dimension A of the front portion will be 50-70% narrower than theanalogous dimension 13 of lateral portions of the compression device.

FIGS. 13-22, 25-32, 35, and 37A disclose modifications of the geometryof the vascular compression members 27 and 46 with respect to thegeometry and anatomy of the patient in order to achieve compression ofcarotid and/or vertebral arteries in any combination.

FIGS. 15, 16, 20, 21B, and 23A demonstrate the method of use and theeffect of inflation of the vascular compression device such as device 26and it's different embodiments resulting in external compression ofcarotid arteries 16 and/or vertebral arteries 12 leading to transientinterruption of carotid and/or vertebral flow. These figures demonstratethe anatomic relationship of the device 26 to carotid arteries 16,vertebral arteries 12 and surrounding structures 34, 35, 36, 37 and 40.The carotid arteries 16 are bordered by neck muscles 36 (comprisingsternocleidomastoid muscles (SCM), scalenus muscles, sternothyroid andomohyoid muscles, longus colli muscles), esophagus 35, trachea 34 andfat tissues 40. These structures provide a protective cushion,minimizing the risk of the carotid and vertebral artery injury duringexternal compression. In fact, an external compression of arteries 16and 12 in this setting would lead to significantly lower risk of injuryto carotid intima than intravascular carotid occlusion with the balloonor umbrella devices used for cerebral protection in patients undergoingcarotid stenting. The longitudinal carotid (42, 46) and/or vertebral(42-V, 46-V) expandable members are positioned along the course of bothcarotid arteries 16 and/or vertebral arteries 12 on the neck. Similarconsiderations are applicable to protective compression of all othercompressible arteries such as femoral and brachial arteries and therepeat description of identical processes is not necessary.

The exemplary embodiment of the device 26 may be any one of thosepreviously disclosed that lacks a transverse carotid expandable member32. However, it is to be understood that this is just one example andthat other devices 26 that include member 32 can function in a similarmanner to the device 26 disclosed in FIGS. 8A and 8B. As shown in FIGS.15, 16, 20, 21B, and 23 longitudinal vascular compression members areplaced along the course of target arteries such as carotid and/orvertebral artery, or brachial and femoral artery, or any othercombination of compressible vessels. The lumen of the target arteriessuch as carotid or vertebral arteries is compressed between the vascularcompression members anteriorly (outward in the radial direction 57) andthe cervical spine 37 (or brachial and femoral bones in the case of thearteries of the extremities) posteriorly (inward in the radial direction57). In some embodiments, the best level of compression of the arteriesmay occur by positioning the compression device and compression membersat a level between the 4th and 7th cervical vertebrae (i.e. between C4and C7 vertebrae of the cervical spine). This level of compression willcorrespond to the portions of the trachea 34 between the thyroidcartilage and the 6th tracheal ring. Actuation of the members 27 and 46and/or 27-V, 46-V cause the members to move radially inward and compressfat tissue 40 that is immediately adjacent the device 26. In the case ofthe carotid artery compression the vascular compression members 27 and46 are shown moving in the radial direction 57 inward of portions of thetrachea 34 and neck muscles 36 so that portions of the vascularcompression members 27 and 46 are closer to the central axis 56 in theradial direction 57 than portions of the trachea 34 and neck muscles 36.Full expansion of the vascular compression members 27 and 46 may resultin inward radial movement so that they are not radially closer to theaxis 56 than any portion of the esophagus 35. However, other embodimentsare possible in which at least some portion, of the vascular compressionmembers 27 and 46 are closer to the central axis 56 than a portion ofthe esophagus 35. Actuation of the compression members 27-V and 46-Vachieve similar compression of the vertebral arteries against thecervical spine, that would be most efficient at the level of C4-C7vertebrae.

The soft tissues such as the fat tissues 40, neck muscles 36, esophagus35 and trachea 34 around carotid arteries 16 provide a smooth cushionassuring adequate protection against carotid trauma. Same considerationswill hold true in the case of compression of the arteries of upper andlower extremities and the repetition of them is not necessary. In thecase of protection of both carotid arteries, the actuation of themembers 27,46 and/or 27-V, 46-V causes the areas of compression torestrict blood flow through the carotid arteries 16 and/or vertebralarteries 12 which leads to transient limitation or interruption ofcerebral flow. The trachea 34 and esophagus 35 are not closed orrestricted upon actuation of the expandable members 27 and 46 due to theplacement and specific configuration of said, expandable members. Thefact that in most cases this maneuver is performed while the patient isintubated and sedated makes the risk of compression of trachea minimal.Performing the same procedure on the ambulatory basis, however, or whilethe patient is not intubated, may prove to be, hazardous. However, insome arrangements some degree of restriction of the trachea 34 and/oresophagus 35 may occur and is considered acceptable in the setting ofgeneral anesthesia with endotracheal intubation and mechanicalventilation. It is advisable, however, to obtain Duplex scan in allpatients planned for this procedure to rule out significantatherosclerotic disease of these vessels, especially if carotid arteries16 are compressed. The mere presence of carotid artery disease in thesepatients should be considered a contraindication to carotid compressiondue to increased risk of carotid atherosclerotic plaque injury leadingper se to distal cerebral embolization and stroke i.e. defeating thepurpose of such a procedure.

The divergence of potential distal emboli such as cerebral emboli 17, 18and prevention of ischemic organ injury such as stroke can be achievedby a noninvasive safe method that involves external compression of thevessel, such as carotid, vertebral or some other arteries and veins,carrying said emboli. The method and device 26 disclosed do not requirepuncture of the skin or vessels and do not necessitate the use ofendovascular devices. The device 26 and disclosed method allow for thedivergence of emboli such as carotid and vertebral emboli 17 and 18 ofall sizes, including those microscopic particles that are too small tobe trapped with the known intravascular filters.

Various types of mechanisms capable of compressing the carotid arteries16, vertebral arteries 12 and other vessels can be included in thedevice 26 in addition to or alternatively to those previously discussed.For example, the device 26 can be supplied with different vascularcompression mechanisms, including different forms and shapes oflongitudinal or transverse bladders, cuffs, compression pads or insertswith the same effect of vascular compression to the point of transientlimitation or interruption of blood flow. The fluid provided topressurize the expandable components of the device 26 from the pressuresource 49 may be a liquid substance in some embodiments. Fluid that is aliquid may be used in the device 26 to effect pressurization and moreuniform constriction of the carotid arteries 16 than gas or air fluidbecause liquid is more non-compressible at the operating range ofpressures. Liquid fluid in members 27, 32 and 46 may more directlytransmit pressure to the carotid area than gas or air fluid.

As previously described and as illustrated in FIG. 14 , a deviceresembling a neck collar may be applied to a patient's neck beforeproceeding, with a surgical intervention. The device (e.g., the deviceof any of FIGS. 13-24D, 37B) may have several pockets and chambers toaccommodate different compression members, such as the compressionmembers described with respect to FIGS. 13-32, 35, 37A. The compressionmembers may be shaped and/or sized to provide for safe, efficient,and/or anatomically sound compression of arteries in the neck. Thecompression members may be replaced, combined, and/or exchangeddepending on the specifics of an anatomy of a particular patient's neck.

As previously described, FIGS. 15 and 16 illustrate a cross-sectionalview of a neck, explaining the specifics of the anatomical position ofthe carotid and vertebral arteries, and the surrounding vitalstructures, as the trachea 34, esophagus 35, jugular vein, spine,brachial plexus, and the sternocleidomastoid or scalenus muscle 36. Insome embodiments, each compression member may have a certain shape,size, and/or configuration aimed at selectively reaching the artery inan anatomical groove of a neck having certain anatomical proportions toprovide compression limited to the artery. For example, the providedcompression could be similar to a doctor's finger reaching into theanatomical groove in the neck of a patient to compress a target bloodvessel. FIGS. 15 and 16 illustrate that the anatomic features of thecarotid area of the neck favor compression using compression membershaving particular cross-sectional shapes, such as a cone shape, pearshape, wedge shape, 2-lobar shape, 3-lobar shape, 1-finger shape,2-finger shape, 3-finger shape, and/or 4-finger shape. A compressionmember having such a cross-sectional shape would be able to enter ananatomical groove between the trachea 34 medially and the neck muscles(e.g., sternocleidomastoid muscle 36) laterally, and reach the bloodvessel to be compressed without encountering resistance from thesurrounding structures of the neck, such as the trachea 34,sternocleidomastoid muscle 34, and the spine, and therefore withoutapplying the same degree of pressure to these structures.

FIGS. 25-31 illustrate example variations of cross-sectional shapes andconfigurations of compression members designed for selective, anatomiccompression of carotid and/or vertebral arteries to prevent embolicstroke. The members may be designed for use alone, or in combinationwith other members, to selectively compress a target neck artery(16-carotid artery and/or 12-vertebral artery) in its anatomical groovewithout the need for overcoming resistance and anatomic barriers createdby surrounding anatomic structures, such as trachea 34, muscle(s) 405(e.g., sternocleidomastoid muscle (SCM) and/or other muscles, such asscalenus muscles, sternothyroid and omohyoid muscles, longus collimuscles), and spine 37. Moreover, one or more of the disclosed shapesare capable of orienting themselves in an optimal position against anartery to be compressed by entering an arterial groove and extendinginto a depth of the arterial groove while being expanded or pressurizedexternally. The arterial groove may be a groove between a trachea 34medially and a muscle (e.g., sternocleidomastoid muscle 405) laterally,and may contain a blood vessel (e.g., carotid artery 420). In otherembodiments, the arterial groove may be a groove between spine 37medially and a muscle (e.g., sternocleidomastoid muscle, longus colliand scalenus muscle 405) laterally, and may contain a vertebral artery.The choice of type and geometry of each particular compression membercan be based on a neck exam and data of a neck CT scan, performed beforea procedure.

As a result, a portion of a compression member, such as a tip of acompression member having a cross-sectional shape that is cone-shaped,wedge-shaped, bilobar shaped, or trilobar shaped, may lodge in betweentrachea 34 and a muscle 405 (e.g., sternocleidomastoid and/or other neckmuscles such as scalenus muscles, longus neck muscles, omohyoid andomothyroid muscles), while reaching directly to vessel 420 (e.g.,carotid artery 16 or vertebral artery 12) in the depth of an arterialgroove. In addition, a wider outer (external) surface of a compressionmember (e.g., a compression member having a cross-sectional shape thatis wedge-shaped, pear-shaped, or cone-shaped) would provide adequatearea for a correct anatomical orientation and stabilization of thecompression member over a target artery 420, such as a carotid artery 16or vertebral artery 12. It will also assure that the pressure forces aretransmitted primarily to the underlying target artery (e.g., carotidartery 16 or vertebral artery 12) and much less to the side structures,such as trachea 34, esophagus 35, and neck muscle 420 (e.g.,sternocleidomastoid and/or other neck muscles, such as the longus colliand scalenus muscles). As a result, application of an outer circular orlocal compression force may urge the compression member to applypressure directly to the artery, and only indirectly (under a certainangle) to side structures (such as trachea 34 medially and muscle 420and a jugular vein laterally).

For example, FIG. 25 illustrates an example of a compression member 410having a conic cross-sectional shape. As shown in FIG. 25 , compressionmember 410 may be narrower at one end of the compression member andwider at the other end. This allows one end of compression member 410 tobe directed into the space between the trachea 34, esophagus 35, spine37 (with transverse process of spine vertebra 425), and a muscle (e.g.,sternocleidomastoid or other neck muscle), to compress artery 420 (e.g.,carotid artery 16, vertebral artery 12), while the other, wider end ofcompression member 410 provides for correct orientation andstabilization of compression member 410 over artery 420. Whencompressed, the main force of the compression may direct compressionmember 410 in the direction of arrow 415, while compression member 410may be directed with small forces (illustrated by the dotted arrows ofFIG. 25 ) onto the surrounding structures (e.g., trachea 34, esophagus35, muscle(s) 405). These small forces may help to orient and/orstabilize compression member 410 over target artery 420.

FIG. 26 illustrates an example of a compression member 435, 440 havingan outer compression member 435 with an arcuate cross-sectional shape incombination with another compression member 440 (e.g., a compressionmember with a cross-sectional shape that is conic-shaped, oval-shaped,or pear-shaped). Compression members 435 and 440 may be formed togetherof the same material (e.g., an inflatable balloon, foam), or be twoseparate members that are fixed together (e.g., with fabric, adhesive).As shown in FIG. 26 , compression member 440 may be narrow at one end,while compression member 435 may be wider than compression member 435.This allows compression member 440 to be directed into the arterialgroove 430, 445 between the trachea 34, esophagus 35, spine 37 (withtransverse process of spine vertebra 425), and a muscle 405 (e.g.,sternocleidomastoid or other neck muscle), to compress artery 420 (e.g.,carotid artery 16, vertebral artery 12), while the wider compressionmember 435 provides for correct orientation and stabilization ofcompression member 440 over artery 420 (e.g., carotid artery 16,vertebral artery 12). When compressed, the main force of the compressionmay direct compression member 440 toward artery 420, while compressionmember 435 may be directed with small forces onto the surroundingstructures (e.g., trachea 34, muscle(s) 405). These small forces mayhelp to orient and/or stabilize compression member 440 over targetartery 420.

FIG. 27 illustrates an example of a compression member 450 with across-sectional shape that is pear-shaped. As shown in FIG. 27 ,compression member 450 may be narrower at one end of the compressionmember and wider at the other. This allows one end of compression member450 to be directed into the space between the trachea 34, esophagus 35,spine 37 (with transverse process of spine vertebra 425), and a muscle(e.g., sternocleidomastoid or other neck muscle), to compress artery 420(e.g., carotid artery 16, vertebral artery 12), while the other, widerend of compression member 450 provides for correct orientation andstabilization of compression member 450 over artery 420. Whencompressed, the main force of the compression may direct compressionmember 450 in the direction of the solid arrow illustrated in FIG. 27 ,while compression member 450 may be directed with small forces(illustrated by the dotted arrows of FIG. 27 ) onto the surroundingstructures (e.g., trachea 34, esophagus 35, muscle(s) 405). These smallforces may help to orient and/or stabilize compression member 450 overtarget artery 420.

FIG. 28 illustrates an example of a compression member 455, 460 havingan outer compression member 455 with a crescent cross-sectional shape incombination with another compression member 460 (e.g., a compressionmember with a cross-sectional shape that is conic-shaped, oval-shaped,or pear-shaped). Compression members 455 and 460 may be formed togetherof the same material (e.g., an inflatable balloon, foam), or be twoseparate members that are fixed together (e.g., with fabric, adhesive).As shown in FIG. 28 , compression member 460 may be narrow at one end,while compression member 455 may be wider than compression member 460.This allows compression member 460 to be directed into the arterialgroove between the trachea 34, esophagus 35, spine 37 (with transverseprocess of spine vertebra 425), and a muscle (e.g., sternocleidomastoidor other neck muscle), to compress artery 420 (e.g., carotid artery 16,vertebral artery 12), while the wider compression member 455 providesfor correct orientation and stabilization of compression member 460 overartery 420 (e.g., carotid artery 16, vertebral artery 12). Whencompressed, the main force of the compression may direct compressionmember 460 toward artery 420 (as illustrated by the arrows ofcompression member 460 adjacent artery 420), while compression member455 may be directed with small forces onto the surrounding structures(e.g., trachea 34, muscle(s) 405) (as illustrated by the arrows adjacentcompression member 455). These small forces may help to orient and/orstabilize compression member 460 over target artery 420.

FIG. 29 illustrates an example of a compression member 465 with across-sectional shape that is finger-shaped. As shown in FIG. 29 ,compression member 465 may be narrower at one end of the compressionmember and wider at the other. This allows the narrower end ofcompression member 465 to be directed into the arterial groove betweenthe trachea 34, esophagus 35, spine 37 (with transverse process of spinevertebra 425), and a muscle (e.g., sternocleidomastoid or other neckmuscle), to compress artery 420 (e.g., carotid artery 16, vertebralartery 12), while the other, wider end of compression member 465provides for correct orientation and stabilization of compression member465 over artery 420. When compressed, the main force of the compressionmay direct compression member 465 in the direction of arrow 470, whilecompression member 465 may be directed with small forces (illustrated bythe dotted arrows of FIG. 29 ) onto the surrounding structures (e.g.,trachea 34, esophagus 35, muscle(s) 405). These small forces may help toorient and/or stabilize compression member 465 over target artery 420.For example, compression of compression member 465 with across-sectional shape that is finger-shaped may mimic a doctor pressinga finger against an artery (e.g., carotid artery 16, vertebral artery12) of a patient.

FIG. 30 illustrates an example of a multiple Finger-shaped compressionmember 470. For example, compression member 470 is illustrated in FIG.30 as being a compression member having a cross-sectional shape that isfour finger shaped. However, a shape representing any number of fingerscould be used (e.g., a compression member having a cross-sectional shapethat is two finger shaped or three finger-shaped). As shown in FIG. 30 ,compression member 470 may be directed into the arterial groove betweenthe trachea 34, esophagus 35, spine 37, and a muscle (e.g.,sternocleidomastoid or other neck muscle), to compress artery 480 (e.g.,carotid artery 16, vertebral artery 12). When compressed, the main forceof the compression may direct the fingers of compression member 470 inthe direction of arrows 475. Use of multiple finger elements in acompression member, such as in compression member 470, may allow acourse of artery 480 to be compressed. For example, compression of acompression member 480 with a cross-sectional shape that is multiplefinger shaped may mimic a doctor pressing multiple fingers against anartery 480 (e.g., carotid artery 16, vertebral artery 12) of a patient.In some embodiments, compression along a longer course of artery 480 mayhelp to minimize flow of blood (and embolic particles) through artery480 to a vulnerable organ.

FIG. 31 illustrates an example of a compression member 485 having abilobar cross-sectional shape. As shown in FIG. 31 , compression member485 may be narrow at one end and wider at the other end. This allows thenarrow end of compression member 485 to be directed into the arterialgroove 430, 445 between the trachea 34, esophagus 35, spine 37 (withtransverse process of spine vertebra 425), and a muscle (e.g.,sternocleidomastoid or other neck muscle), to compress artery 420 (e.g.,carotid artery 16, vertebral artery 12), while the wider end ofcompression member 485 provides for correct orientation andstabilization of compression member 485 over artery 420 (e.g., carotidartery 16, vertebral artery 12). When compressed, the main force of thecompression may direct compression member 485 toward artery 420 in thedirection 490, while compression member 485 may be directed with smallforces onto the surrounding structures (e.g., trachea 34, muscle(s)405). These small forces may help to orient and/or stabilize compressionmember 485 over target artery 420, while an outer portion of compressionmember 485 may rest on surrounding structures, such as a trachea 34medially and a sternocleidomastoid or anterior scalenus muscle 405laterally.

FIG. 32 illustrates an example of a self-centering andstructure-spreading effect of a compression member 505 with a coniccross-section shape leading to compression of an artery 420 (e.g.,carotid artery 16, vertebral artery 12), while the conic cross-sectionalshape of compression member 505 causes the compression member toautomatically position itself between surrounding structures (e.g.,trachea 34, esophagus 35, muscle(s) 405) when compressed. As illustratedin A of FIG. 32 , prior to an emboligenic event, compression may not beapplied to compression member 505, and compression member 505 may bealigned next to the skin 515 of a patient's neck outside an arterialgroove 510. As illustrated in B of FIG. 32 , when a small amount ofcompression is applied, compression member 505 may be pressed againstthe skin 515 of a patient and directed into arterial groove 510, but maynot compress artery 420. As illustrated in C of FIG. 32 , when amoderate or high amount of compression is applied, compression member505 may be further directed into arterial groove 510 than in B, whichmay cause a narrow end of compression member 505 to be wedged into thespace between the trachea 34, esophagus 35, spine 37, and a muscle(e.g., sternocleidomastoid or other neck muscle), to compress artery 420(e.g., carotid artery 16, vertebral artery 12), while the other, widerend of compression member 410 may provide for correct orientation andstabilization of compression member 505 over artery 420. Whencompressed, the main force of the compression may direct compressionmember 505 in the direction toward artery 420, while compression member505 may be directed with small forces onto the surrounding structures(e.g., trachea 34, esophagus 35, muscle(s) 405). These small forces mayhelp to orient and/or stabilize compression member 505 over targetartery 420.

FIGS. 33-35 explain the mechanism of action of carotid and/or vertebralcompression members, and of carotid compression in general. For the sakeof simplicity, the scalenus muscles located laterally from the vertebralarteries and the longus colli muscle, located medially to the vertebralarteries, are not depicted.

FIG. 33 illustrates the concept of “inter-carotid distance.”Inter-carotid distance 520 is the distance between the right and leftcarotid arteries as measured by the anterior circumference of the neck.In some embodiments, this distance must correspond to the distancebetween inner parts of compression members of a compression device forcompressing carotid arteries. This measurement may be essential toestablish adequate distance between the right and left compressionmembers in order to assure adequate, precise, and/or selectivecompression of carotid arteries 16, and to position the compressionmembers over the course of the arterial groove of the carotid artery 16,i.e., between the trachea 34 medially and muscle(s) 420 laterally.Similar principles may be applied for positioning compression membersfor the compression of vertebral arteries 12, where the arteries arecompressed by compression members positioned in the groove between theneck muscles 36, such as a scalenus muscle laterally and the spine 37and the transverse process of the spine 425 medially and posteriorly,and the longus colli muscle medially. For easier measurement, a set oftemplates (sizers) can be used. A template (sizer) can be applied to theanterior surface of the neck for better estimation of the distancebetween the carotid arteries and the corresponding carotid compressionmembers, and/or for better estimation of the distance between thevertebral arteries and the corresponding vertebral compression members.Such templates may be part of a kit for carotid and/or vertebralcompression. Before an emboligenic procedure, a patient can be measuredwith one or more of the templates to determine the inter-carotiddistance (or inter-vertebral distance), and an appropriately-sized neckcollar having appropriate distance between the compression members canthen be chosen for use on the patient.

FIG. 34 illustrates the concept of “carotid bridging.” Carotid bridgingrefers to a situation where a compression member is substantially longerthan a gap that is formed between a lateral wall of the trachea 34 andan adjacent muscle 405 (e.g., sternocleidomastoid muscle) on one or bothsides of the neck. For example, line 550 of FIG. 34 illustrates astraight plane between trachea 34 and a muscle 405 (e.g.,sternocleidomastoid muscle). The gap can correspond to the width of anarterial groove, where a compression member of a specificcross-sectional shape is supposed to enter to achieve compression of atarget artery. Hinge point 535 illustrated in FIG. 34 represents a pointat the front of the trachea from which intersects a straight planebetween a medial structure (e.g., trachea 34) and a lateral structure(e.g., sternocleidomastoid, scalenus, longus colli, and/or other neckmuscles) on either side of the neck. Angle 555 represents an anglebetween the two planes that intersect hinge point 535. Thecross-sectional shapes, sizes, combinations, and/or configurations ofcompression members disclosed herein are designed to fill the gapbetween one or more medial structures, such as trachea 34, and one ormore, lateral structures, such as muscle 405 (e.g., sternocleidomastoid,scalenus, longus colli muscles, and/or other neck muscles). However, ifthe width of the compression member is substantially longer than thewidth of the groove, the member may not be able to reach a target arteryat the bottom of the groove. Accordingly, the compression member may actas a bridge over the artery, such as a carotid artery 12, resting ontrachea 34 medially and one or more muscles 405 (e.g., SCM and/or otherneck muscles such as scalenus and long us colli muscles) laterally withthe artery located deeper, where, it cannot be reached to achieveadequate compression. For example, a distance 540, 545 between the skin515 of the patient's neck and the artery 16 may be such that acompression member wider than the gap between a medial structure (e.g.,trachea 34) and a lateral structure (e.g., sternocleidomastoid,scalenus, longus colli, and/or other neck muscles) cannot compressartery 16 without much higher pressures, which could cause the degree oftrauma to surrounding organs and structure to be much more significant.Similar principles may apply to the compression of the vertebral artery12 and the repetition of these details is not necessary.

FIG. 35 illustrates an example of a “tracheal hinge,” and an example ofan “angle of hinging.” As shown in FIG. 35 , a hinge (“tracheal hinge”)may be provided at a location in the compression device so that, whenplaced at the neck of a patient, the hinge is located at, or within ashort distance (e.g., within 1 centimeter) of, the hinge point (e.g.,hinge point 535 of FIG. 34 ) to address possible issues of carotidbridging as discussed with respect to FIG. 35 . For example, A of FIG.35 illustrates a circular compression member 565 placed at the skin 515of the neck of a patient. As can be seen from A of FIG. 35 , carotidbridging of the compression device occurs between a medial structure(e.g., trachea 34) and a lateral structure (e.g., sternocleidomastoid,scalenus, longus colli, and/or other neck muscles 405), causing thecompression member 565 to be a distance a 570 from target artery 16.Hinge point 560 of FIG. 35 corresponds to the point at which planesextending from the medial structure to the lateral structure on eitherside of the neck would intersect.

As illustrated in B of FIG. 35 , the possible issues of carotid bridgingof FIG. 34 and A of FIG. 35 can be resolved by providing a hinge 575 inthe compression device. Hinge 575 may be placed at a location of thecompression device so, when the compression device is aligned with apatient's neck, hinge 575 is at the hinge point 560, or within a shortdistance (e.g., 1 centimeter) of hinge point 560. Hinge 575 of thecompression device may allow an angle 580 of hinging to be controlled byan operator of the compression device (e.g., a doctor, nurse) to achieveoptimal compression of an artery 16 (e.g., carotid and/or vertebralartery), while preventing undue compression of trachea 34 and esophagus35 medially and jugular vein laterally. A forward prominence of trachea34 may ordinarily prevent a circular compression mechanism, such as aneck collar, from adequate compression of a carotid artery that isrunning much deeper in a vascular groove. Therefore, it may be useful toutilize a hinging mechanism, such as hinge 575, in order to create aparticular angle between left and right extensions of a carotidcompression device carrying compression members. This angle may, forexample, be between 70 and 130 degrees at the trachea, providing forbetter contact between the carotid and/or vertebral compression membersand the underlying arteries. In some embodiments, if the angle isgreater than 130 degrees, or less than 70 degrees, a target artery maynot be adequately compressed. However, in some embodiments, the angle atthe hinge may be between 35 degrees and 140 degrees when the compressionmembers are actuated.

To achieve a certain angle with a hinging mechanism, such as hinge 575,a special compliant and flexible part in an anterior segment of thecompression collar may be used. The anterior segment of the compressioncollar may be free of compression members and/or rigid components. Theanterior segment of the compression collar may also be capable ofavoiding a convex arch aimed anteriorly over an anterior surface of apatients neck. Without such a hinge or a compliant portion of thecompression device, the compression device may form an arch externally,thereby preventing inward compression of a target artery in a vasculargroove. Conversely, a hinge, or an angle of the compression device, thatis between 70 degrees and 130 degrees, may allow for a deeper positionof a carotid and/or vertebral compression member in a vascular grooveand therefore closer contact and more selective and efficientcompression of an artery (e.g., carotid artery 16, vertebral artery 12).Such a curvature would assure a more direct contact between thecompression members and carotid artery and/or vertebral artery grooveand may prevent a bridging effect of a neck compression device (aspreviously described) that would prevent optimal compression of a targetartery. For example, B of FIG. 35 illustrates that, as a result of thehinging mechanism (e.g., hinge 575), the distance 590 between acompression member 585 of a compression device and a target artery 16 isless than the distance 570 between compression member 565 of acompression device and target artery 16.

FIG. 36 illustrates an example mechanism of optimizing bilateral carotidcompression using a particular range of angles α 615-β 620 between alongitudinal axis of a target carotid artery and/or vertebral artery anda longitudinal axis of a compression member. For example, in someembodiments, a compression member of a compression device may be angledsuch that, when positioned and compressed against a neck of a patient, aparticular angle is formed between a longitudinal axis of thecompression member and a longitudinal axis 605 of a target artery 625.In some embodiments, the angle may be between 0 degrees and 65, ascontact between a compression member and an underlying carotid 16 orvertebral 12 artery may require the least amount of pressurization orcompression at these angles, and may therefore be most efficient and/orsafe at these angles. In some embodiments, the angle between alongitudinal axis of a compression member and a longitudinal axis of atarget artery may be between 30 degrees and 65 degrees to assure adesired compression of a carotid and/or vertebral artery even if ananatomical position of the carotid and/or vertebral artery cannot beascertained (such as in a patient with a short and/or thick neck).

In some embodiments, a vascular probe 220 (e.g., a pulse oximeter and/orDoppler probe) can be added to the inner surface of a compression member(shown for example in FIGS. 23B and 23C), or to an inner surface (shownfor example in FIG. 21B) of the neck collar. The vascular probe couldfacilitate a search for a target artery and document a correct positionof a compression member and/or an adequacy of arterial compression.Moreover, in some embodiments, a vascular Doppler probe may detectembolic particles inside the artery, by registering the high intensitytransient signals (HITS) from the carotid arteries 16 and/or vertebralarteries 12 (analogous to the detection of embolic signals bytranscranial Doppler) thus prompting the compression device to getactuated and to compress said arteries for prevention of cerebralemboli. Such actuation may be achieved automatically according to thefeedback mechanism described above (FIGS. 3-7 ), or on the command by ahealth provider once the emboli passing through the arteries aredetected.

FIGS. 37A-C illustrate example parts of a carotid and/or vertebralcompression kit. For example, as illustrated in FIG. 37A, kit mayinclude a range of one or more compression members. The compressionmembers may have different cross-sectional shapes and/or sizes. One ormore compression members having different cross-sectional shapes may beincluded in a kit and may include, for example, a compression memberhaving a cross-sectional shape that is oval shape 705, conic (or conus)shape 710, pear shape 715, bilobar or trilobar shape 720, combined shape735 combining two shapes 725 and 750, mixed solid and inflatable shape730 having a solid compression member 745 and an inflatable compressionmember that expands from an unexpanded configuration 750 to an expandedconfiguration 755, a multiple finger shape 760 having multiple fingershapes 765, a single finger shape 770, or any other shape that wouldallow a majority of a force of compression to be delivered to an artery,with lesser forces being applied to structures proximate to the artery.Additionally, different sized compression members may be provided foruse on patient's having differing neck anatomies. For example, smallersized compression members may be provided for use on individuals withsmaller necks (e.g., children), while larger sized compression membersmay be provided for use on individual with larger necks (e.g., adultswith large necks). In some embodiments, the compression members, such asthose illustrated in FIG. 37A, may comprise foam. In some embodiments,the compression members, such as those illustrated in FIG. 37A, may beexpandable members that inflate when pressurized. In some embodiments,some of the compression members illustrated in FIG. 37A may comprisefoam, while others may be expandable. The cross-sectional shapes for oneor more of the compression members illustrated in FIG. 37A may be thecompression members cross-sectional shape when at rest and/or whenactuated. Providing a kit with different cross-sectional shapes and/orsizes may allow an individual (e.g., doctor, nurse) fitting a patientwith the compression device to select a cross-sectional shape and/orsize of one or more compression members that achieves the mostanatomically congruent fit into an arterial groove of a carotid 16and/or vertebral 12 artery. Such a selection for a particular case canbe based on a neck exam, or a neck CT scan, which allows the delineationof the precise neck anatomy of a particular patient.

As illustrated in FIG. 37B, the kit may include one or more adjustablecompression devices, such as adjustable neck compression collars. One ormore of the compression devices may include one or more pockets (e.g.,insertion pockets) and/or attachments 810 that allow for placement andremoval of compression members. The compression devices may bedifferently sized, such that the pockets and/or attachments are spaceddifferently from, one compression device to another, allowingdifferential spacing of compression members depending on the compressiondevice selected for use. A compression device may include straps 26, 33for encircling the compression device around a patient's neck. Acompression device may also include attachment patches 44, 45 (e.g.,hook and loop fastener), which allow the compression device to besecured around a patient's neck. In some embodiments, a compressiondevice can be tightened or loosened (e.g., with a loop) so that a singlecompression device can be used for patients having necks of slightlydifferent size. A compression device may also include a hinge, which mayallow an angle of the two sides of the compression device to beadjusted, such as that discussed with reference to FIGS. 34 and 35 . Acompression device may also include a buckle 805, which may provide anoption to increase a length of the device to extend the inter-carotiddistance between the compression members, or to tighten the collar todecrease the inter-carotid distance between the compression members.

As illustrated in FIG. 37C, the kit may include one or more neck sizingtemplates. The neck sizing templates may have different sizes andcurvatures, and may allow an individual to measure a distance between aright and left carotid artery over an anterior neck surface of apatient. The templates may be made out of any type of material, such asplastic, metal, wood, or paper. To measure the distance between carotidarteries or vertebral arteries of a patient, a right side (R) 820 may bealigned with a right artery (e.g., carotid artery 16, vertebral artery12), and a left side (L) 825 may be aligned with a left artery (e.g.,carotid artery 16, vertebral artery 12). Each of the templates may havea defined size, so that when left and right ends of a particulartemplate align with the left and right carotid or vertebral arteries ofa patient, the inter-carotid or inter-vertebral distance will be known.Alternatively, an adjustable template may be provided with measurementsalong the template, where the template can expand or contract to alignwith the patient's carotid and/or vertebral arteries in order to providea measurement of the distance between the arteries.

A kit, such as the example kit described above with respect to FIGS.37A-C, may be designed to fulfill a doctor's demand at any particularsituation when there is a need for selecting an optimal cross-sectionalshape and/or curvature of a compression device, and an optimalcross-sectional shape and/or size of one or more carotid and/orvertebral compression elements for a particular patient, depending onthe size, curvature, thickness, and/or anatomy of the patient's neck.For example, for a patient with a larger neck and/or a widerinter-carotid (or inter-vertebral) distance as measured with a template,a larger compression device, such as a compression collar with a largerdistance between compression members may be chosen. Conversely, for apatient with a thinner neck and/or a smaller inter-carotid distance asmeasured with a template, a narrower compression device with a lesserdistance between compression members may be chosen.

A neck compression device, such as a neck compression collar, may havean option for adjusting its length and a distance between compressionmembers using an anterior and/or posterior strap, connecting two halvesof the circumferential neck collar anteriorly or posteriorly.

One or more of the compression members used in the neck compressioncollar may be actuated by virtue of insufflation of air, gas, and/orfluid, and may be in a fluid continuity with a pressure source that isactivated and released on-demand. In other embodiments, compressionmembers may be solid or partially compliant components, or a combinationof solid, partially compliant (e.g., foam), and/or other components, forbetter compression of underlying arteries.

Further, although shown as employing a single pressure source 49, it isto be understood that multiple pressure sources of different types maybe used. For instance, the transverse carotid expandable member 32 maybe pressurized by a first pressure source 49 such as a pump, tighteningor direct compressing mechanism while a second source of pressure ofsimilar types is included in the device 26 to provide pressure to thetwo longitudinal vascular compression members 27 and 46.

A monitoring system 58 may be included with the device 26 to assure asafe, adequate, easily manageable and controllable compression ofcarotid, vertebral and other vessels. The monitoring system 58 maycomprise Doppler ultrasound, Doppler probe, oscillotonometry,electroencephalography, transcranial Doppler, echocardiography, cerebraloximetry and/or other techniques. The device 26 may be actuated to sucha degree that the one, two or more areas of vascular compression formedcompletely stop the flow of blood into the distal artery such as carotidartery 22, or to an extent that partial flow of blood passes through theareas of compression 23 and into the distal artery such as carotidartery 22.

The device 26 provided is a noninvasive and precise apparatus with anoption of assessing a degree and an effectiveness of an interruption ofthe arterial flow by the optional inclusion of a monitoring system 58.The device 26 assures a uniform and reproducible interruption orlimitation of the arterial flow bilaterally minimizing the risk oftrauma to the artery compressed such as carotid and vertebral artery andsubsequent distal emboli, such as cerebral emboli 17. An alarm system 59can be included in the device 26 that is triggered by excessive orlengthy compression of the target artery, such as carotid arteries 16,brachial or femoral arteries. In addition the alarm may be triggered bythe appearance of the potential vascular emboli in, the vessels ofinterest. Such an appearance may be detected by the vascular Doppler,analogous to the transcranial Doppler, or by thoracic or transesophagealechocardiography (ECHO) that would show echogenic signals inside thevessels, representing potential emboli. The alarm system 59 may be apart of the monitoring system 58 or may be a different component that isnot part of the monitoring system 58. The alarm system 59 may thusmeasure the time of compression, and the magnitude of compression.Constant monitoring of arterial, such as carotid 16, brachial or femoraland systemic arterial and device 26 pressures with pressure in thedevice 26 exceeding only slightly the pressure in the arterial systemmay be conducted to ensure safe operation and use of the discloseddevice 26. The device 26 provides a noninvasive compression apparatusthat does not require the insertion of intravascular devices.

A method for reducing or totally preventing cerebral emboli will now bediscussed. A brief compression of arteries to be protected from emboli,such as carotid arteries 16 and vertebral arteries 12 by way of a device26 may be performed first to assure adequate position of the deviceleading to reduction or interruption of flow or pulse through saidartery as assessed by carotid Doppler, a pressure gauge, percutaneouscerebral oximetry or transcranial Doppler.

Once an adequate position of the device 26 is confirmed, the pressure inthe vascular compression components (27, 32, 46 and/or 27-V, 32-V, 46-V)is released and the apparatus 26 is ready for use. The device 26 isinflated to the pressure exceeding patient's systemic pressure justbefore proceeding with the emboligenic part of the procedure. Adequatecompression of the target arteries such as carotid arteries 16 will leadto divergence of blood and emboli away from the vessels to be protectedand toward more distal less important arteries, thus decreasing the riskof deadly complications, such as stroke.

The pressure in the device 26, and thus to the vascular compressioncomponents 27, 32, 46 and/or 27-V, 32-V, 46-V is released after theemboligenic procedure is completed after a full washout of potentialemboli 20, 18 from the heart 11, thoracic aorta and all other potentialsources. The pressurization of the device 26 and its differentcompartments can be repeated any time and on multiple occasions when theemboligenic intervention is contemplated.

Should the physician or physician's assistant forget to release arterialcompression timely, an alarm would go off and the pressure would bereleased spontaneously to avoid undue interruption of the arterial flow.The alarm and deflation could be overridden by the physician whenclinically indicated. The alarm may be sounded by the alarm system 59,and the deflation may be activated by the pressure source 49 and/or thealarm system 59 and/or the monitoring system 58.

The central axis 56 may be present even when the device 26 is notconfigured with straps 33, 43 to form a generally circular member whenviewed from the top as for example in FIG. 6A. In some embodiments ofthe device 26, a circular member is not formed when viewed from the topby the straps 33, 43. For instance, the straps 33, 43 may be missingsuch that the section 31 is attached to sides of a bed or otherwisesecured so that the device 26 is located at the neck of the patient. Insuch instances, the central axis 56 is still present. The central axis56 may be located at a location within the neck of the patient, forexamples shown with reference to FIGS. 8A and 8B. This location may beat the spinal column 37 of the patient, or may be at the center of theneck of the patient. It is to be understood that various embodiments ofthe device 26 exist in which the device 26 does not wrap completelyaround the neck of the patient but instead only wraps around a portionof the neck of the patient less than 360 degrees fully about the neck ofthe patient.

The apparatus and methods discussed herein are not limited to thedetection and compression of any particular vessels or combination ofvessels, but can include any number of different types of vessels. Forexample, in some aspects, vessels can include arteries or veins. In someaspects, the vessels can be suprathoracic vessels (e.g., vessels in theneck or above), vessels in the thorax, vessels in the abdominal area orbelow, vessels to the sides of the thorax such as vessels in theshoulder area and beyond), blood vessels of the upper and lowerextremities, or other types of vessels and/or branches thereof.

In some aspects, the detection and compression systems disclosed hereincan be applied to suprathoracic vessels. The suprathoracic vessels cancomprise at least one of intracranial vessels, cerebral arteries, and/orany branches thereof. For example, the suprathoracic vessels cancomprise at least one of a common carotid artery, an internal carotidartery, an external carotid artery, a lacrimal (ophthalmic) artery, anaccessory meningeal artery, an anterior ethmoidal artery, a posteriorethmoidal artery, a maxillary artery, a posterior auricular artery, anascending pharyngeal artery, a vertebral artery, a left middle meningealartery, an anterior, middle, and/or posterior cerebral artery, asuperior cerebellar artery, a basilar artery, a left internal acoustic(labyrinthine) artery, an anterior inferior cerebellar artery, aposterior inferior cerebellar artery, a deep cervical artery, a highestintercostal artery, a costocervical trunk, a subclavian artery, a middlecerebral artery, an anterior cerebral artery, an anterior communicatingartery, an ophthalmic artery, a posterior communicating artery, a facialartery, a lingual artery, a superior laryngeal artery, a superiorthyroid artery, an ascending cervical artery, an inferior thyroidartery, a thyrocervical trunk, an internal thoracic artery, and/or anybranches thereof. The suprathoracic vessels can also comprise at leastone of a medial orbitofrontal artery, a recurrent artery (of Heubner),medial and lateral lenticulostriate arteries, a lateral orbitofrontalartery, an ascending frontal (candelabra) artery, an anterior choroidalartery, pontine arteries, an internal acoustic (labyrinthine) artery, ananterior spinal artery, a posterior spinal artery, a posterior medialchoroidal artery, a posterior lateral choroidal artery, and/or branchesthereof. The suprathoracic vessels can also comprise at least one ofperforating arteries, a hypothalamic artery, lenticulostriate arteries,a superior hypophyseal artery, an inferior hypophyseal artery, ananterior thalamostriate artery, a posterior thalamostriate artery,and/or branches thereof. The suprathoracic vessels can also comprise atleast one of a precentral (pre-Rolandic) and central (Rolandic)arteries, anterior and posterior parietal arteries, an angular artery,temporal arteries (anterior, middle and posterior), a paracentralartery, a pericallosal artery, a callosomarginal artery, a frontopolarartery, a precuneal artery, a parietooccipital artery, a calcarineartery, an inferior vermian artery, and/or branches thereof.

In some aspects, the suprathoracic vessels can also comprise at leastone of diploic veins, an emissary vein, a cerebral vein, a middlemeningeal vein, superficial temporal veins, a frontal diploic vein, ananterior temporal diploic vein, a parietal emissary vein, a posteriortemporal diploic vein, an occipital emissary vein, an occipital diploicvein, a mastoid emissary vein, a superior cerebral vein, efferenthypophyseal veins, infundibulum (pituitary stalk) and long hypophysealportal veins, and/or branches thereof.

The vessels can comprise the aorta, pulmonary artery, or branchesthereof. For example, the vessels can comprise at least one of anascending aorta, a descending aorta, an arch of the aorta, and/orbranches thereof. The descending aorta can comprise at least one of athoracic aorta, and/or any branches thereof. The vessels can alsocomprise at least one of a subclavian artery, pulmonary artery, abrachiocephalic trunk, and/or a pulmonary artery.

In some aspects, the vessels can also comprise at least one of a rightinternal jugular vein, a right brachiocephalic vein, a subclavian vein,an internal thoracic vein, a pericardiacophrenic vein, a superior venacava, a right superior pulmonary vein, a left brachiocephalic vein, aleft internal jugular vein, a left superior pulmonary vein, an inferiorthyroid vein, an external jugular vein, a vertebral vein, a righthighest intercostal vein, a 6th right intercostal vein, an azygos vein,an inferior vena cava, a left highest intercostal vein, an accessoryhemiazygos vein, a hemiazygos vein, and/or branches thereof.

In some aspects, the vessels can comprise at least one of renalarteries, inferior phrenic arteries, a celiac trunk with common hepatic,left gastric and splenic arteries, superior suprarenal arteries, amiddle suprarenal artery, an inferior suprarenal artery, a right renalartery, a subcostal artery, 1st to 4th right lumbar arteries, iliacarteries or veins, femoral arteries or veins, popliteal arteries orveins, tibial arteries and veins, and saphenous veins, an iliolumbarartery, an internal iliac artery, lateral sacral arteries, an externaliliac artery, a testicular (ovarian) artery, an ascending branch of deepcircumclex iliac artery, a superficial circumflex iliac artery, aninferior epigastric artery, a superficial epigastric artery, a femoralartery, and/or branches thereof. The vessels can also comprise at leastone of a superior mesenteric artery, a left renal artery, an abdominalaorta, an inferior mesenteric artery, colic arteries, sigmoid arteries,a superior rectal artery, 5th lumbar arteries, a middle sacral artery, asuperior gluteal artery, umbilical and superior vesical arteries, anobturator artery, (obturator anastomotic) branches of inferiorepigastric artery, a left colic, artery, rectal arteries, and/orbranches thereof.

In some aspects, the vessels can comprise at least one of humeralarteries, a transverse cervical artery, a suprascapular artery, a dorsalscapular artery, and/or branches thereof. The vessels can also compriseat least one of an anterior circumflex humeral artery, a posteriorcircumflex humeral artery, a subscapular artery, a circumflex scapularartery, a brachial artery, a thoracodorsal artery, a thoracic artery, aninferior thyroid artery, a thyrocervical trunk, a subclavian artery, asuperior thoracic artery, a thoracoacromial artery, and/or branchesthereof.

In some aspects, vessels can include other portions of the vasculature,such as the heart or chambers of the heart. In some aspects, thedetection and compression systems disclosed herein can be applied to theheart or chambers of the heart, such as the right atrium, the leftatrium, the right ventricle, and/or the left ventricle. For example,detection of emboli can be performed within or near one or more chambersof the heart.

In-some aspects, a vessel in which detection is performed is differentfrom a vessel in which compression is performed. For example, detectionis performed in a first vessel and compression is performed in a secondvessel. The second vessel can be downstream of the first vessel.

In some aspects, a vessel in which detection is performed is the same asa vessel in which compression is performed. For example, detection isperformed in a vessel at a first location and compression is performedin the vessel at a second location. The second location can bedownstream of the first location.

FIG. 25 is a block diagram illustrating an exemplary computer system 200with which a system (e.g., monitoring module/system and/or detectionmodule/system) of the subject technology can be implemented. In certainembodiments, the computer system 200 may be implemented using hardwareor a combination of software and hardware, either in a dedicated server,or integrated into another entity, or distributed across multipleentities.

The computer system 200 includes a bus 208 or other communicationmechanism for communicating information, and a processor 202 coupledwith the bus 208 for processing information. By way of example, thecomputer system 200 may be implemented with one or more processors 202.The processor 202 may be a general-purpose microprocessor, amicrocontroller, a Digital Signal Processor (DSP), an ApplicationSpecific Integrated Circuit (ASIC), a Field Programmable Gate Array(FPGA), a Programmable Logic Device (PLD), a controller, a statemachine, gated logic, discrete hardware components, and/or any othersuitable entity that can perform calculations or other manipulations ofinformation.

The computer system 200 can include, in addition to hardware, code thatcreates an execution environment for the computer program in question,e.g., code that constitutes processor firmware, a protocol stack, adatabase management system, an operating system, or a combination of oneor more of them stored in an included memory 204, such as a RandomAccess Memory (RAM), a flash memory, a Read Only Memory (ROM), aProgrammable Read-Only Memory (PROM), an Erasable PROM (EPROM),registers, a hard disk, a removable disk, a CD-ROM, a DVD, and/or anyother suitable storage device, coupled to the bus 208 for storinginformation and instructions to be executed by the processor 202. Theprocessor 202 and the memory 204 can be supplemented by, or incorporatedin, special purpose logic circuitry.

The instructions may be stored in the memory 204 and implemented in oneor more computer program products, i.e., one or more modules of computerprogram instructions encoded on a computer readable medium for executionby, or to control the operation of, the computer system 200, andaccording to any method well known to those of skill in the art,including, but not limited to, computer languages such as data-orientedlanguages (e.g., SQL, dBase), system languages (e.g., C, Objective-C,C++, Assembly), architectural languages (e.g., Java, .NET), and/orapplication languages (e.g., PHP, Ruby, Pert, Python). Instructions mayalso be implemented in computer languages such as array languages,aspect-oriented languages, assembly languages, authoring languages,command line interface languages, compiled languages, concurrentlanguages, curly-bracket languages, dataflow languages, data-structuredlanguages, declarative languages, esoteric languages, extensionlanguages, fourth-generation languages, functional languages,interactive mode languages, interpreted languages, iterative languages,list-based languages, little languages, logic-based languages, machinelanguages, macro languages, metaprogramming languages, multi paradigmlanguages, numerical analysis, non-English-based languages,object-oriented class-based languages, object-oriented prototype-basedlanguages, off-side rule languages, procedural languages, reflectivelanguages, rule-based languages, scripting languages, stack-basedlanguages, synchronous languages, syntax handling languages, visuallanguages, with languages, and/or xml-based languages. The memory 204may also be used for storing temporary variable or other intermediateinformation during execution of instructions to be executed by theprocessor 202.

A computer program as discussed herein does not necessarily correspondto a file in a file system. A program can be stored in a portion of afile that holds other programs or data (e.g., one or more scripts storedin a markup language document), in a single file dedicated to theprogram in question, or in multiple coordinated files (e.g., files thatstore one or more modules, subprograms, or portions of code). A computerprogram can be deployed to be executed on one computer or on multiplecomputers that are located at one site or distributed across multiplesites and interconnected by a communication network. The processes andlogic flows described in this specification can be performed by one ormore programmable processors executing one or more computer programs toperform functions by operating on input data and generating output.

The computer system 200 further includes a data storage device 206 suchas a magnetic disk or optical disk, coupled to the bus 208 for storinginformation and instructions. The computer system 200 may be coupled viaan input/output module 210 to various devices (e.g., devices 214 and216). The input/output module 210 can be any input/output module.Exemplary input/output modules 210 include data ports (e.g., USB ports),audio ports, and/or video ports. In some embodiments, the input/outputmodule 210 includes a communications module. Exemplary communicationsmodules include networking interface cards, such as Ethernet cards,modems, and routers. In certain aspects, the input/output module 210 isconfigured to connect to a plurality of devices, such as an input device214 and/or an output device 216. Exemplary input devices 214 include akeyboard and/or a pointing device (e.g., a mouse or a trackball) bywhich a user can provide input to the computer system 200. Other kindsof input devices 214 can be used to provide for interaction with a useras well, such as a tactile input device, visual input device, audioInput device, and/or brain-computer interface device. For example,feedback provided to the user can be any form of sensory feedback (e.g.,visual feedback, auditory feedback, and/or tactile feedback), and inputfrom the user can be received in any form, including acoustic, speech,tactile, and/or brain wave input. Exemplary output devices 216 includedisplay devices, such as a cathode ray tube (CRT) or liquid crystaldisplay (LCD) monitor, for displaying information to the user.

According to certain embodiments, the computer system 200 can operate inresponse to the processor 202 executing one or more sequences of one ormore instructions contained in the memory 204. Such instructions may beread into the memory 204 from another machine-readable medium, such asthe data storage device 206. Execution of the sequences of instructionscontained in the memory 204 causes the processor 202 to perform theprocess steps described herein. One or more processors in amulti-processing arrangement may also be employed to execute thesequences of instructions contained in the memory 204. In someembodiments, hard-wired circuitry may be used in place of or incombination with software instructions to implement various aspects ofthe present disclosure. Thus, aspects of the present disclosure are notlimited to any specific combination of hardware circuitry and software.

Various aspects of the subject matter described in this specificationcan be implemented in a computing system that includes a back endcomponent (e.g., a data server), or that includes a middleware component(e.g., an application server), or that includes a front end component(e.g., a client computer having a graphical user interface and/or a Webbrowser through which a user can interact with an implementation of thesubject matter described in this specification), or any combination ofone or more such backend, middleware, or front end components. Thecomponents of the system 200 can be interconnected by any form ormedium, of digital data communication (e.g., a communication network).Examples of communication networks include a local area network and awide area network.

The term “machine-readable storage medium” or “computer readable medium”as used herein refers to any medium or media that participates inproviding instructions to the processor 202 for execution. Such a mediummay take many forms, including, but not limited to, non-volatile media,volatile media, and transmission media. Non-volatile media include, forexample, optical or magnetic disks, such as the data storage device 206.Volatile media include dynamic memory, such as the memory 204.Transmission media include coaxial cables, copper wire, and fiberoptics, including the wires that comprise the bus 208. Common forms ofmachine-readable media include, for example, floppy disk, a flexibledisk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM,DVD, any other optical medium, punch cards, paper tape, any otherphysical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASHEPROM, any other memory chip or cartridge, or any other medium fromwhich a computer can read. The machine-readable storage medium can be amachine-readable storage device, a machine-readable storage substrate, amemory device, a composition of matter effecting a machine-readablepropagated signal, or a combination of one or more of them.

As used herein, a “processor” can include one or more processors, and a“module” can include one or more modules.

In an aspect of the subject technology, a machine-readable medium is acomputer-readable medium encoded or stored with instructions and is acomputing element, which defines structural and functional relationshipsbetween the instructions and the rest of the system, which permit theinstructions' functionality to be realized. Instructions may beexecutable, for example, by a system or by a processor of the system.Instructions can be, for example, a computer program including code. Amachine-readable medium may comprise one or more media.

FIG. 26 illustrates an example of a system 300 for diverting emboliwithin a patient, in accordance with various embodiments of the subjecttechnology. The system 300 is an example of an implementation of asystem for diverting emboli within a patient. The system 300 comprisesmonitoring module 302, compression module 304, and control module 306.Although the system 300 is shown as having these modules, the system 300may have other suitable configurations. The modules of the system 300may be in communication with one another. In some embodiments, themodules may be implemented in software (e.g., subroutines and code). Forexample, the modules may be stored in the memory 204 and/or data storage206, and executed by the processor 202. In some aspects, some or all ofthe modules may be implemented in hardware (e.g., an ApplicationSpecific Integrated Circuit (ASIC), a Field Programmable Gate Array(FPGA), a Programmable Logic Device (PLD), a controller, a statemachine, gated logic, discrete hardware components, or any othersuitable devices) and/or a combination of both. Additional features andfunctions of these modules according to various aspects of the subjecttechnology are further described in the present disclosure.

As used herein, the word “module” refers to logic embodied in hardwareor firmware, or to a collection of software instructions, possiblyhaving entry and exit points, written in a programming language, suchas, for example C++. A software module may be compiled and linked intoan executable program, installed in a dynamic link library, or may bewritten in an interpretive language such as BASIC. It will beappreciated that software modules may be callable from other modules orfrom themselves, and/or may be invoked in response to detected events orinterrupts. Software instructions may be embedded in firmware, such asan EPROM or EEPROM. It will be further appreciated that hardware modulesmay be comprised of connected logic units, such as gates and flip-flops,and/or may be comprised of programmable units, such as programmable gatearrays or processors. The modules described herein are preferablyimplemented as software modules, but may be represented in hardware orfirmware.

It is contemplated that the modules may be integrated into a fewernumber of modules. One module may also be separated into multiplemodules. The described modules may be implemented as hardware, software,firmware or any combination thereof. Additionally, the described modulesmay reside at different locations connected through a wired or wirelessnetwork, or the Internet.

In general, it will be appreciated that the processors can include, byway of example, computers, program logic, or other substrateconfigurations representing data and instructions, which operate asdescribed herein. In other embodiments, the processors can includecontroller circuitry, processor circuitry, processors, general purposesingle-chip or multichip microprocessors, digital signal processors,embedded microprocessors, microcontrollers and the like.

Furthermore, it will be appreciated that in one embodiment, the programlogic may advantageously be implemented as one or more components. Thecomponents may advantageously be configured to execute on one or moreprocessors. The components include, but are not limited to, software orhardware components, modules such as software modules, object-orientedsoftware components, class components and task components, processesmethods, functions, attributes, procedures, subroutines, segments ofprogram code, drivers, firmware, microcode, circuitry, data, databases,data structures, tables, arrays, and variables.

A phrase such as “an aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples of the disclosure. A phrasesuch as “an aspect” may refer to one or more aspects and vice versa. Aphrase such as “an embodiment” does not imply that such embodiment isessential to the subject technology or that such embodiment applies toall configurations of the subject technology. A disclosure relating toan embodiment may apply to all embodiments, or one or more embodiments.An embodiment may provide one or more examples of the disclosure. Aphrase such “an embodiment” may refer to one or more embodiments andvice versa. A phrase such as “a configuration” does not imply that suchconfiguration is essential to the subject technology or that suchconfiguration applies to all configurations of the subject technology. Adisclosure relating to a configuration may apply to all configurations,or one or more configurations. A configuration may provide one or moreexamples of the disclosure. A phrase such as “a configuration” may referto one or more configurations and vice versa.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefine herein may be applied to other configurations. Thus, many changesand modifications may be made to the subject technology, by one havingordinary skill in the art, without departing from the scope of thesubject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

Reference to an element in the singular is not intended to mean “one andonly one” unless specifically stated, but rather “one or more.” Pronounsin the masculine (e.g., his) include the feminine and neuter gender(e.g., her and its) and vice versa. The term “some” refers to one ormore. Underlined and/or italicized headings and subheadings are used forconvenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

While certain aspects and embodiments of the subject technology havebeen described, these have been presented by way of example only, andare not intended to limit the scope of the subject technology. Indeed,the novel methods and systems described herein may be embodied in avariety of other forms without departing from the spirit thereof. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thesubject technology.

What is claimed is:
 1. A device for diverting emboli from a cerebralcirculation of a patient, comprising: a first compression memberconfigured to be applied to a first artery of the patient when thedevice is placed around a neck of the patient, the first compressionmember having an unactuated state and an actuated state, wherein thefirst compression member has an anatomically congruent cross-sectionalshape configured such that, when in the actuated state, the firstcompression member applies a greater amount of force on the first arterythan on a trachea or a sternocleidomastoid muscle of the patient; asecond compression member configured to be applied to a second artery ofthe patient when the device is placed around the neck of the patient,the second compression member having an unactuated state and an actuatedstate, wherein the second compression member has an anatomicallycongruent cross-sectional shape configured such that, when in theactuated state, the second compression member applies a greater amountof force on the second artery than on the trachea or asternocleidomastoid muscle of the patient; a vascular probe on an innersurface of the first compression member that detects the presence ofemboli in the first artery; and a monitoring system that receives inputfrom the vascular probe and upon receiving input from the vascular probethat emboli is no longer detected in the first artery causes the firstcompression member to be moved from the actuated state of the firstcompression member to the unactuated state of the first compressionmember, wherein upon the detection of emboli by the vascular probe themonitoring system causes the first compression member to be moved fromthe unactuated state of the first compression member to the actuatedstate of the first compression member upon receiving a command by ahealth care provider.
 2. The device of claim 1, further comprising: athird compression member configured to be applied to a third artery ofthe patient when the device is placed around the neck of the patient,the third compression member having an unactuated state and an actuatedstate, wherein the third compression member has an anatomicallycongruent cross-sectional shape configured such that, when in theactuated state, the third compression member applies a greater amount offorce on the third artery than on a longus colli muscle, a scalenusanterior muscle, and a sternocleidomastoid muscle of the patient; and afourth compression member configured to be applied to a fourth artery ofthe patient when the device is placed around the neck of the patient,the fourth compression member having an unactuated state and an actuatedstate, wherein the fourth compression member has an anatomicallycongruent cross-sectional shape configured such that, when in theactuated state, the fourth compression member applies a greater amountof force on the fourth artery than on a longus colli muscle, a scaleneanterior muscle, and a sternocleidomastoid muscle of the patient.
 3. Thedevice of claim 1, wherein a cross sectional shape of the firstcompression member is a pear shape.
 4. The device of claim 1, whereinthe second compression member comprises a crescent cross-sectional shapeouter member and an inner compression member that is more narrow in acircumferential direction than the crescent cross-sectional shape outermember and located radially inward from the crescent cross-sectionalshape outer member and is conic in shape.
 5. The device of claim 1,wherein at least one of the first compression member or the secondcompression member is inflatable.
 6. The device of claim 1, wherein thedevice has a hinge positioned between the first compression member andthe second compression member, wherein the hinge is configured to beactuated to adjust one of a distance between the first compressionmember and the first artery and a distance between the secondcompression member and the second artery.
 7. The device of claim 6,wherein the hinge can be actuated to adjust an angle formed by the hingebetween a side of the device comprising the first compression member anda side of the device comprising the second compression member, whereinthe angle is between 35 degrees and 140 degrees when the firstcompression member and the second compression member are in theiractuated states.
 8. The device of claim 1, wherein the vascular probe isa Doppler probe configured to detect embolic particles in the firstartery.
 9. The device of claim 1, wherein the vascular probe is aDoppler probe or a pulse oximeter configured to detect a correct amountof compression on the first artery.
 10. The device of claim 1, whereinthe first compression member has a cross-sectional multiple finger shapeand is configured to compress along a length of the first artery. 11.The device of claim 1, wherein the vascular probe is a Doppler probe ora pulse oximeter configured to detect a position of the first artery.12. A device for diverting emboli from a cerebral circulation of apatient, comprising: a first compression member configured to be appliedto a first artery of the patient when the device is placed around a neckof the patient, the first compression member having an unactuated stateand an actuated state, wherein the first compression member has ananatomically congruent cross-sectional shape configured such that, whenin the actuated state, the first compression member applies a greateramount of force on the first artery than on a trachea or asternocleidomastoid muscle of the patient; a second compression memberconfigured to be applied to a second artery of the patient when thedevice is placed around the neck of the patient, the second compressionmember having an unactuated state and an actuated state, wherein thesecond compression member has an anatomically congruent cross-sectionalshape configured such that, when in the actuated state, the secondcompression member applies a greater amount of force on the secondartery than on the trachea or a sternocleidomastoid muscle of thepatient; a vascular probe on an inner surface of the first compressionmember; and a buckle that is located between the first compressionmember and the second compression member and is configured to increasean inter-carotid distance between the first compression member and thesecond compression member, and is configured to decrease theinter-carotid distance between the first compression member and thesecond compression member.
 13. A neck collar for diverting emboli from acerebral circulation of a patient, comprising: an inner surface; a firstcompression member configured to be applied to a first artery of thepatient when the neck collar is placed around a neck of the patient, thefirst compression member having an unactuated state and an actuatedstate, wherein the first compression member has an anatomicallycongruent cross-sectional shape configured such that, when in theactuated state, the first compression member applies a greater amount offorce on the first artery than on a trachea or a sternocleidomastoidmuscle of the patient, wherein the first compression member is pearshaped with a convex shaped end that is oriented towards the firstartery and moves towards the first artery upon entering the actuatedstate; a second compression member configured to be applied to a secondartery of the patient when the neck collar is placed around the neck ofthe patient, the second compression member having an unactuated stateand an actuated state, wherein the second compression member has ananatomically congruent cross-sectional shape configured such that, whenin the actuated state, the second compression member applies a greateramount of force on the second artery than on the trachea or asternocleidomastoid muscle of the patient; and a vascular probe on theinner surface of the neck collar.
 14. The neck collar of claim 13,wherein the vascular probe is a Doppler probe configured to detectembolic particles in the first artery.
 15. The neck collar of claim 13,wherein the vascular probe is a Doppler probe or a pulse oximeterconfigured to detect a position of the first artery.
 16. A device fordiverting emboli from a cerebral circulation of a patient, comprising: afirst compression member configured to be applied to a first artery ofthe patient when the device is placed around a neck of the patient, thefirst compression member having an unactuated state and an actuatedstate, wherein the first compression member has an anatomicallycongruent cross-sectional shape configured such that, when in theactuated state, the first compression member applies a greater amount offorce on the first artery than on a trachea or a sternocleidomastoidmuscle of the patient, wherein the first compression member has a solidsection and an inflatable section that is inflated in the actuatedstate, wherein the inflatable section is configured to be located closerto the first artery than the solid section, wherein the solid sectionextends a greater distance in a circumferential direction than does theinflatable section; and a second compression member configured to beapplied to a second artery of the patient when the device is placedaround the neck of the patient, the second compression member having anunactuated state and an actuated state, wherein the second compressionmember has an anatomically congruent cross-sectional shape configuredsuch that, when in the actuated state, the second compression memberapplies a greater amount of force on the second artery than on thetrachea or a sternocleidomastoid muscle of the patient; a vascular probeon an inner surface of the device that detects emboi; an upstream embolidetector that detects emboli; a monitoring system that receives inputfrom the vascular probe and the upstream emboli detector that indicatesemboli detection, wherein the monitoring system upon the indication ofemboli causes the first and second compression members to be moved fromthe unactuated states into the actuated states.